Short takes: Stryker to buy Care.ai, Masimo W1 medical watch clears FDA for oxygen, heart monitoring, Create Health Ventures forms $21M fund

August 16, 2024 | by

Medical/surgical device giant Stryker snapping up Care.ai. Price and financing are not disclosed. Orlando-based Care.ai specializes in sensor-based smart room technologies for hospitals and post-acute care facilities along with virtual care data analysis and workflows. Timing of the closing is based upon the usual regulatory approvals and Care.ai will operate separately until then. After that, it’s projected that it will be integrated into Stryker’s 2022 acquisition Vocera Communications’ platform and devices.  Care.ai may be just the first deal for Stryker’s second half, as their CEO Kevin Lobo promised on the Q2 investor call a “very active deal pipeline” of tuck-in acquisitions. According to HIStalk, Care.ai co-founder and CEO Chakri Toleti sold his previous venture, HealthGrid, to Allscripts (now Veradigm) in 2018 for $60 million. MedTech Dive, Stryker release

Despite the proxy fight, business as usual goes on with Masimo. Their W1 medical watch for remote patient monitoring, integrated into the Masimo SafetyNet telemonitoring platform, received FDA 510(k) clearance. The watch MW-1 module monitors high-resolution SpO2, pulse rate, perfusion index (Pi), and heart rate from an ECG from a single wearable device. Readouts are both on desktop for the clinician and on an app for patients and caregivers. All can receive customized notifications and manage care remotely. The Masimo W1 medical watch and the integrated Masimo MW-1 module are indicated for adults in hospitals, clinics, long-term care facilities, and homes. No cost is provided and it is not available on the website, but the W1 Sport consumer version is $549.  SleepReview, Masimo product page.

Another sign of digital health investment revival–a new venture capital fund not started by Glen Tullman. Create Health Ventures is kicking off its inaugural fund with $21 million. Its focus will be on early-stage startups founded by experienced healthcare veterans on two tracks, according to their announcement release: 

  1. For payers, improve access to care for everyone, enhance the patient experience, and facilitate better health outcomes
  2. For pharmaceutical companies, technologies they can use to recruit and retain patients for clinical trials, as later-stage trial needs swell in the industry

The two founders and managing partners, who started the firm in Austin and Chicago in 2021, are Emma Cartmell and Amit Aysola. They have advised or invested in over 80 companies. Venture Capital Journal, Mobihealthnews

Short takes: both Clover and Oscar in the black; Aetna prez booted after 11 months; Ava-VSee bedside robot; updates on Change, OneBlood ransomware, Masimo proxy fight

August 8, 2024 | by

Clover Health’s milestone–a first-ever profitable operating quarter. Not only that, but it was an impressive turnaround from the prior year. With results in their Q2 operating net income of $7.2 million, versus a $28.9 million loss in 2023, these results were far more favorable directionally than the adjusted EBITDA which was $36.2 million versus $9.9 million for the prior year. Insurance revenue was also up 11% to $349.9 million, attributed to member retention and an improved medical cost ratio (MCR) of 71.3%, down from 77.9% in the prior year. Additional revenue from other operations, such as the recently introduced Assistant AI, is minimal. The 2024 forecast stays ‘in the clover’ with raised forecast revenue of $1.35 to $1.375 billion and adjusted EBITDA of $50 million to $65 million. Also helpful is their lifted Star rating from 3 to 3.5 for 2025. FierceHealthcare, Clover earnings release

Rival Oscar Health also stayed Back in Black for the second quarter running–CEO Bertolini wouldn’t have it any other way (or else–see below right). Q2 net income rose to $56.2 million which was a a $71.7 million improvement versus prior year. Adjusted EBITDA also nicely improved to $104.1 million, a $68.6 million improvement. Revenue increased to $2.2 billion, a 46% increase over the prior year. Their MCR went down .9 points. The overall forecast for the year wasn’t provided. Membership was up over 600,000 in their main business of individual and small group insurance, with Bertolini pointing out that this was powered by plan growth in 80% of the states where they operate. Oscar exited Medicare Advantage at the end of 2023, and is shifting to marketing ICHRA, or individual coverage health reimbursement arrangements that permit small businesses to offer employees individual health plans subsidized by employer contributions. After this year, the 58,000 members left in the unprofitable Cigna co-branded small group program will exit [TTA 10 May]. Oscar release, FierceHealthcare

Back in Mr. Bertolini’s old stand, Aetna, results weren’t so cheerful–and their president walked the plank after less than one year. The reorganization announcement was made on the earnings call yesterday, effective immediately. CVS Health CEO Karen Lynch will oversee the daily operations of the health benefits segment along with Aetna’s CFO. CVS VP/chief strategy officer Katerina Guerraz will move over to become Aetna’s chief operating officer.

What initiated it: while health benefits’ revenue stayed in the black, going the wrong way were operating income decreasing 39.1%, the medical benefits ratio (MBR) soaring to 90% from 86% in prior year and the medical loss ratio (MLR) going up to 89.6% from 86.2%. These were attributed to increased utilization, the decline in Medicare Advantage Star ratings, Medicaid acuity, and a revised risk adjustment in the individual exchange business. Something in this immediately doomed now former president Brian Kane, who joined only last September. His last post was at Humana as chief financial officer and leader of their primary care business. CVS Health release, FierceHealthcare, Healthcare Finance

Marrying robots with telemedicine, VSee is partnering with Ava Robotics to create an autonomous robot for telepresence use in hospital intensive care units. This would enable remote emergency physicians to be present at the point of patient care, interact with patients, consult with onsite staff and make treatment decisions. The projected market is smaller regional hospitals and ICUs.  VSee already markets telemedicine carts and portable diagnostic and home care kits. Availability is not disclosed. VSee release, Mobihealthnews

VSee also announced a partnership with Wichita, Kansas community health provider Stand Together for its Aimee telehealth services. Telehealth at their centers will be available to participants for a monthly charge of $4.99 or a single virtual urgent care appointment for $9.99. VSee release

Ransomware strikes again. Non-profit blood donation organization OneBlood was hit on 29 July by a despicable ransomware attack that disabled much of its blood collection services for over 250 hospitals in the southeastern US. They continued to operate at reduced capacity and called for donors of O positive blood, O negative blood and platelet donations. The perpetrator, ransom demands, and breached information were not disclosed. On Monday 5 August, systems were partially restored in time for Tropical Storm Debby’s assault on many southeastern states. From a OneBlood spokesperson: “Our critical software systems have cleared reverification and are operating in a reduced capacity. As we begin to transition back to an automated production environment, manual labeling of blood products will continue. Additionally, we are beginning to return to using our electronic registration process for donors.” DataBreaches.net, FierceHealthcare, HealthcareITNews

Hard-hit Change Healthcare is still playing games with reporting to HHS’ Office of Civil Rights (OCR). Parent UnitedHealth Group reported the ransomware shutdown and data breach to OCR, a full five months after its occurrence. The number reported is the OCR minimum of 500, when it is well known that it affected millions of patients. UHG started direct patient notification on 31 July after weeks of delay, but stated to OCR that they are still determining the number of individuals affected. Provider notifications started in late June [TTA 21 June]. This followed after a hostile dispute earlier that month where UHG tried to push patient notifications onto providers, which HHS decided was 100% UHG’s responsibility. [TTA 5 June]. OCR FAQ update, HealthcareITNews

Masimo and activist shareholder Politan Capital continue to slug it out down to the 19 September shareholders meeting. Back in mid-July, Masimo postponed the meeting, originally scheduled for 25 July. At that time, Masimo filed a complaint in the US District Court for the Central District of California against the two Politan representatives on their board of directors plus Politan’s two nominees that proxy materials contained false statements and violations of the Exchange Act. The suit added that board member Quentin Koffey, also Politan’s chief investment officer, was secretly conspiring with a plaintiffs’ bar law firm currently in litigation with Masimo.

The latest revelation per Strata-gee 7 August: Politan’s countersuit in the Delaware Court of Chancery states that the charges filed by Masimo in the District Court are based on ‘unnamed sources received from a third-party opposition research firm…’ and Masimo’s outside counsel does not know the identity nor ever spoke to the sources. This was filed against CEO Joe Kiani, independent director Craig Reynolds, and director Bob Chapek as a breach of Delaware law.

To date, Masimo has not confirmed their sources to the Delaware court. 

As previously reported [TTA 17 July], the proxy fight was triggered by the value of the company, reduced substantially after Masimo’s snakebit 2022 acquisition of Sound United’s consumer audio brands, Politan’s move to control the company, and kick out the CEO Joe Kiani.  The fight on the Masimo board of directors for two open seats pits the Masimo slate of CEO Joe Kiani and outside candidate Christopher Chavez, against Politan’s Darlene Solomon and William Jellison. Politan already holds two seats and with a win of two additional seats will control the company. Masimo plans to sell the consumer audio and healthcare (baby monitoring) businesses to another unnamed investor, retaining their professional healthcare and pulse oximetry products.

Stay tuned to the next episode of this soap opera.

Masimo v. Politan goes into extra innings with two-month shareholder meeting delay, mucho maneuvering

July 17, 2024 | by

In the history of proxy battles and hostile takeovers, Masimo v. Politan may be one for the business and law school case histories. The latest moves by health tech monitoring (and sound) company Masimo are to sue–both metaphorically for extra time and literally in a Federal court.

  • Masimo postponed on Tuesday 16 July their shareholder meeting, originally scheduled for next week–Thursday 25 July–to Thursday 19 September. The revised proxy statement will be filed with the Securities and Exchange Commission (SEC). This not only allows shareholders additional time to review materials but also, as requested by Politan Capital Management, a later ‘record date’  (deadline for share ownership) of 12 August. 
  • The downside of the postponement is that any shareholders who have already voted their proxies must vote again. Downside #2:  in this Editor’s view, conceding this allows Politan to accumulate additional shares beyond their current 9%.
  • Another reason for the delay: in a California Federal court, Masimo has filed for an injunction that seeks to force Politan Capital to correct “material misstatements and omissions” in its proxy materials.
  • Masimo also alleges in the complaint that Quentin Koffey, Politan’s chief investment officer and the company’s representative on Masimo’s board of directors, has assisted Politan’s counsel in litigation against Masimo.

The fight on the Masimo board of directors for two open seats pits the Masimo slate of CEO Joe Kiani and outside candidate Christopher Chavez, against Politan’s Darlene Solomon and William Jellison. Politan already holds two seats and with a win of two additional seats will control the company. Two outside proxy advisors, ISS and Glass Lewis have recommended that Masimo shareholders support both Politan nominees. Glass Lewis in particular accuses Masimo and Kiani in a form of proxy manipulation called ’empty voting’ by a 9.9% shareholder named RTW, a $5.9 billion fund described by Joe Kiani on the RTW website as a decades-long ‘trusted partner.’

Countering this are multiple conditional resignations from managers to leadership that would be effective if Politan controls the company, which would constitute a pyrrhic victory.

The bone of contention started in 2022 with the tussle over Masimo’s $1 billion purchase of Sound United’s consumer audio business, which made their share price crater. Masimo announced last week [TTA 10 July] plans to sell a substantial portion of that consumer audio and healthcare business to a to-date unnamed investor. MedTech Dive, Strata-gee.com, Masimo release

A few days earlier, Strata-gee summarized Masimo’s preliminary financials for Q2 2024 as strong for the Healthcare division with revenues of $344 million, up 22% at $63 million or 22% versus $281 million in Q2 2023. But the Sound United unit sank these good results with a 13% decline in revenues to $152 million–a decline that has been fairly consistent. Masimo needs to find another investor or sell off Sound United.

Stay tuned!

News roundup: Masimo has offer to JV consumer business for $950M or more, Get Well sold to SAI, One Medical scored on poor handling of urgent calls from Iora patients

July 10, 2024 | by

Slow early July? Not quite.

Masimo’s maneuvering continues with a potential $950 million offer to buy into its consumer audio and health business. The unnamed offeree listed in Masimo’s latest Form 8-K is a potential joint venture (JV) investor negotiating with Masimo since 7 May. Masimo would sell off the majority stake of its consumer audio and consumer health businesses to the partner, that would make 1) a cash payment to Masimo and 2) contribute cash. The 2 July update confirms that the potential partner is offering in the range of $850 million to $950 million on a cash and debt free basis. It’s by no means a done deal as Masimo is pressing for more cash and for retaining certain intellectual property rights. For instance, Masimo’s IP would be for use solely within the consumer field, not healthcare. The Apple litigation on IP infringement on their pulse oximetry (SpO2) sensors and software would remain with Masimo.

The consumer audio business would include the international audio brands acquired in the $1 billion buy of Sound United in 2022: Bowers & Wilkins, Denon, Polk Audio, Marantz, Definitive Technology, Classé, and Boston Acoustics. Their consumer healthcare includes smartwatches and the Stork baby monitor.  MedTechDive

This is an interesting Act 3 Curtain Raiser to Masimo’s ongoing proxy fight with ‘activist investor’ Politan Capital Management, which is attempting to take two more seats on the board of directors and wrest control from the current board controlled by CEO/founder Joe Kiani. Hundreds of Masimo staff have threatened to resign if Politan takes over. The shareholder meeting is on 25 July. TTA 2 July

Get Well, a patient engagement platform, has been acquired by SAIGroup for an undisclosed amount. Get Well serves health plans and systems with patient engagement at point of care, digital care plans, and AI-enabled care navigation. SAI will integrate their existing advanced predictive + generative Eureka AI platform into Get Well’s offerings. SAIGroup has two other AI-related companies in its portfolio: ConcertAI and generative AI RhythmX AI. Michael O’Neil will continue as Get Well Founder and CEO. Release    Hat tip to HIStalk 7/10/24

A story highly critical of Amazon’s One Medical broke over the holiday weekend with a PBS News story about patients put at risk by sloppy call handling. The patients were former Iora Health members, acquired with One Medical, who are older 65+ adults in Medicare Advantage and Medicare Shared Savings Programs (MSSP) ACOs including the advanced ACO REACH model. In March, calls to Iora Health offices were shifted to what Amazon termed ‘mission control’ in Tempe, Arizona. The call center reps did not have access to their records and were not medically trained. The patients were calling with acute symptoms–one of 17 ‘red flag’ symptoms such as symptoms of a blood clot, sudden rib pain, stomach pain and blood in their stool. At the call center, they were not triaged to immediate assistance and instead were given appointments later that day or later in the week. Amazon is claiming that as far as they know, no patients were harmed. Becker’s

As TTA backgrounded on 6 March, the former Iora offices were rebranded, if not closed, as One Medical Senior and they would shift to existing One Medical offices. FTA: Existing patients, many with multiple chronic conditions, reported cutbacks in callbacks, appointment length, physician load, and services provided such as transportation. One clinic had 20 staff cut back to five with patients pushed out to virtual visits–hardly appropriate for a high needs, older, less technologically savvy patient population in value-based care, quality-measured models.

How will these high care needs patients in tightly monitored, intensive programs such as MA and ACO REACH, mesh with the cheap efficient approach that Amazon takes with everything–including One Medical?

Follow up roundup: Amwell to reverse stock split to avoid delisting (updated), Amazon Clinic folded into One Medical, Amedisys divesting to close UHG deal, latest on Steward Health’s antics and $7M spying, Masimo’s shareholder fight (latest)

July 2, 2024 | by

Amwell will reverse stock split to fix their pending delisting on the NYSE. The board of directors approved on 28 June a 1 for 20 reverse split. This will remedy their non-compliance with NYSE regulations requiring an average closing price of above $1.00 over a consecutive 30 trading-day period [TTA 5 Apr]. Shareholders approved the move at their meeting on 18 June. The NYSE notice was given on 2 April and the reverse split will happen at the market open on 11 July, well within the six-month window. Amwell Class A shares closed yesterday at $0.27 so that condensing 20 shares will bring the share price around $5.40. Amwell’s 2024 is forecast with revenue in the range of $259 to $269 million and adjusted EBITDA in the (less) red between ($160) million to ($155) million, with no breakeven in sight until 2026. Their Q1 posted a $73.4 million net loss. Amwell has also released 10% of staff since the palmier days of 2023. Amwell, like Teladoc, continues to struggle in a stand-alone urgent care model that is now obsolete. Release, Healthcare Dive

Update 11 July: Amwell shares opened today at $6.52, and as of midday were trading at $7.51. So short term, the reverse split is working to plump up the shares.

Amazon says goodbye to Amazon Clinic by folding it into One Medical. This should come as no surprise to Readers who noted the  May departure of Clinic’s general manager Nworah Ayogu, MD to VC Thrive Capital with no replacement or search. Amazon’s announcement on 27 June was typically upbeat in renaming the service as One Medical’s Pay-per-visit telehealth. The improvements they claim are:

  • Pay-per-visit telehealth for 30+ common but minor conditions, like pink eye, the flu, or a sinus infection
  • A One Medical monthly or annual membership plan that includes on-demand virtual care and same or next-day appointments at 150+ One Medical primary care offices
  • More affordable–messaging/asynchronous visits are now $29, formerly $35, and video visits at $49, formerly $75. 

The catch–existing Clinic members have to log into One Medical to access their records and the service. Amazon is also propping up One Medical through Prime membership, offering a better deal at $99/year and non-Prime individuals for $199 per year. Amazon does not disclose users, growth, or revenue for either Clinic or One Medical. Healthcare Dive

The long-delayed UnitedHealth-Amedisys home health deal moves closer to closing. Amedisys and UHG’s home health operation under Optum will be divesting some of their locations to VitalCaring Group to avoid Department of Justice anti-trust concerns. The divestiture is contingent on the acquisition closing, now projected in second half of this year. The number of locations was not disclosed though earlier speculation had estimated it at 100. UHG’s offer to acquire Amedisys was made in June 2023 for $3.3 billion in an all-cash deal. It would be additive to its earlier $5.4 billion buy of LHC Group, now part of Optum. With the divestiture, analysts do not see any impediments to a closing, though it had faced opposition in Oregon in March and DOJ opposition since it was announced. This Editor remains sanguine about a successful closing. After UHG won versus DOJ in the Change Healthcare acquisition, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.” Expect a few more impediments tossed in their direction over the next months. FierceHealthcare , Zack’s Research

The latest episodes in the continuing soap opera of Steward Health involve both Optum and James Bond moves on their critics. Optum had offered back in March to buy their practice groups under Stewardship Health, which stalled with first the Massachusetts Health Policy Commission (HPC), then their bankruptcy. That offer is now off, leaving Steward in the lurch. It was critical to $75 million of Steward’s debtor-in-possession (DIP) financing as recently as 13 June [TTA 14 June]. The deal would have been problematic anyway for Optum as they are under DOJ scrutiny not only for Amedisys but also because Optum controls or has arrangements with 10% of US physicians, 90,000 to date. Healthcare Dive They also settled recently with DOJ for $20 million on Optum Rx’s filling orders from a mail-order pharmacy in Carlsbad, California between 2013 and 2015 for Schedule II drugs: opioids, benzodiazepines, and muscle relaxants. Healthcare Dive

Adding to Steward’s piles of misery are the latest revelations that Steward financed a $7 million spy operation on their critics. This loony aspect to the Steward endgame involved contracting with UK investigators on surveilling a critical former executive, a British financial analyst, and a Maltese politician to find compromising actions between 2018 and 2023. The investigations were allegedly authorized and prioritized by Steward’s top executives while Steward struggled to pay bills for its hospitals and practices. Payments to the investigators were routed through Steward’s Malta operation against their critics in Malta and elsewhere. Steward at the time was embroiled in a dispute around their management of hospitals in Malta, which was eventually investigated and terminated by a Maltese court last year.

One example: the UK firm Audere “collected embarrassing personal information and photographs of a former Steward employee after Steward feared he would leak financial information to its auditor.” Another was the investigation and harassment of a British financial analyst, Fraser Perring, critical of Steward’s actions in its dealings with Medical Properties Trust (MPT). He was followed, his home CCTV was disabled, his home was broken into, family members and his partner were followed. Perring was also being smeared on Twitter through an account set up by Audere. There is much more on this in OCCRP’s report, published (paywalled) in the Boston Globe and Times of Malta. OCCRP’s full report and findings are here. FierceHealthcare

Electronics, audio, and medical device company Masimo continues to fight a hostile activist investor, Politan Capital Management. In December 2023, Masimo notched a significant win via the International Trade Commission versus Apple’s Series 6 and later Watches that forced Apple to disable its pulse oximetry (SpO2) sensors and software that violated Masimo’s smartwatch patents [TTA 28 Dec 2023]. Politan descended on Masimo in April accusing CEO and chairman Joe Kiani and others of mismanagement, including the 2022 acquisition of Sound United’s audio brands. It won two seats on the Masimo board of directors at the last shareholders’ meeting and is demanding two more seats at this year’s meeting on 25 July which would give it effective control.

The latest in the proxy fight is that the chief operating officer, Bilal Muhsin, will depart after 24 years at Masimo if Joe Kiani is forced out. The brief conditional resignation was sent to Masimo’s lead independent director, Craig Reynolds. Mentioned in the resignation was that he would refuse to work with Quentin Koffey, a Masimo director and chief investment officer of Politan Capital. More letters like this may be coming as reportedly Masimo management has urged employees to sign similar letters. Strata-gee, MedTech Dive  

Politan was the investment group that upended Centene Corporation and ousted most of Centene’s board plus 25-year CEO Michael Neidorff in 2022 shortly before his death on 7 April 2022 [TTA 18 Dec 2021]

Update: 300 engineers in Masimo’s healthcare division expressed specific support for Joe Kiani against Politan and Quentin Koffey in an open letter. “We wish to convey our deepest concern if Quentin Koffey and Politan Capital take control and Joe Kiani is removed. We are committed to Masimo because of the vision and innovation he pushes and drives us to deliver. The prospect of losing our founder and CEO threatens to derail the progress we have made and jeopardize the future of Masimo.” They also expressed that they may leave. “We, the undersigned from Masimo Healthcare Engineering, wanted you to be aware that we may not continue with the company if Joe Kiani is replaced by Quentin Koffey and Politan Capital.” This follows on other letters written by international regional managers and presidents in June also stating their support and warning that they may leave if Kiani leaves. The annual shareholder meeting is scheduled for 25 July.   MedTech Dive

However, Masimo is also embattled on other fronts: earlier in June, DOJ and FDA announced their investigation of problems with their Rad-G and Rad-97 SpO2 devices leading to a recall and the SEC is investigating potential accounting irregularities and internal control deficiencies. MedTechDive

Davids (AliveCor, Masimo) v. Goliath (Apple): the patent infringement game *not* over; Masimo’s messy proxy fight with Politan (updated)

April 4, 2024 | by

Apple’s legal department certainly hasn’t been maxing their relaxing this year, what with DOJ and pesky upstarts taking them to court. The big one keeping them busy is the US Department of Justice (DOJ) giving Apple a dose of its own medicine in filing an antitrust lawsuit against Apple for monopolizing smartphone markets [TTA 22 Mar]. Apple also continues to fight antitrust and intellectual property (patent) infringement in Federal district courts, the US Patent and Trademark Office (USPTO)’s Patent Trial and Appeal Board (PTAB), and the International Trade Commission (ITC), brought by ECG reader AliveCor and Masimo‘s pulse oximetry reader and software. Masimo succeeded in disrupting Apple’s sales of the Watch Series 9 and Ultra 2 right at the Christmas holiday sales season [TTA 28 Dec 23], forcing Apple to disable the pulse ox feature [TTA 18 Jan] in future imports in one of Apple’s few losses.

The DOJ lawsuit does not address Apple’s copycat activities against either AliveCor or Masimo. Both companies worked with Apple.  AliveCor integrated its early KardiaBand (2016) with early Apple Watches, only to have cardiac readings integrated into the Apple Watch two years later (2018). Masimo and Apple were in mid-stages of a 2021 partnership that Apple broke off, but Masimo then accused Apple of hiring its employees working on the project [TTA 27 Oct 23].

AliveCor hasn’t been quite so successful as Masimo in challenging Apple, but it has been fighting Apple as a David v Goliath on multiple fronts for years. In February, AliveCor lost a round in the US District Court for the Northern District of California on the heart rate algorithm changes Apple made in 2018 that made their SmartRhythm app provided to Apple non-functional. That decision reportedly is still under seal. However, AliveCor has multiple Federal patent infringement lawsuits going against Apple. The differing rulings of the PTAB against and an ITC ruling finding for AliveCor went to the Federal circuit court level. According to CEO Priya Abani in an excellent MedCityNews article, AliveCor expects to see action on this by summer. Abani also scored Apple’s annoying (understatement) habit of IP infringement and broken partnerships. “Apple’s vast resources allow them to squash small innovators,” she said. “They have more lobbyists and lawyers on their payroll than we have employees.”

AliveCor and Masimo aren’t the only ones battling Apple. In the MedCityNews article, NYU Langone cardiologist Joseph Wiesel has sued Apple on patent infringement on his atrial fibrillation app (2021), also involving the USPTO, an action that is wending its way through courts now. While this Editor has long been mystified by Apple’s continued combativeness against small innovative companies when certainly it would be cheaper (and more respectful) to pay a license or settlement, FTA in MedCityNews citing Dr. Wiesel’s attorney Andrew Bochner, “Apple is known among the legal community to have a certain modus operandi: they do “not entertain any sort of real settlement discussions” and instead battle “tooth and nail” in order to wear out their rivals with fewer resources.” The shocker here is that Apple, in this case, stated to Bochner that it filed “roughly 10%” of the USPTO’s total post-grant proceedings, which take place after a patent has been granted and generally challenge a patent’s validity. One wonders whether DOJ will even take note of this anticompetitive activity involving Apple Watches in its blunderbuss action on iPhones and the US smartphone market.

Masimo itself is being roiled by a shareholder proxy fight over who controls the company. Masimo is a publicly-traded (Nasdaq) electronics company that is primarily focused on health devices, including smartwatches, and data software monitoring for the clinical and consumer markets, notably pulse oximetry.

  • Last week, activist investor group Politan Capital Management accused CEO Joe Kiani and others of mismanagement, announcing the nomination of two more independent candidates from Politan for the board of directors. Politan already has two seats on the BOD and a win here would give Politan majority control.
  • The bone being picked is Masimo’s February 2022 $1 billion acquisition of consumer audio brand Sound United (Polk, Marantz, Denon, and others) which didn’t mesh well with their health tech business. This drove down the share price from that time, with Politan subsequently swooping in and picking up shares, successfully winning two BOD seats in 2023.
  • Masimo announced on 22 March that their consumer ‘hearables’ division would be spun off.
  • Politan’s response on 26 March was to object to the spinoff on governance grounds, nominate the additional directors, and heavily criticize CEO Kiani’s ‘control and influence’. Strata-gee 26 March

Yesterday’s follow-up is that Kiani and Masimo are rebutting all of Politan’s claims and more. Strata-gee 2 April, Masimo release 1 April, MedTechDive

This Editor notes that products in their personal monitoring line combine both audio and vital signs monitoring–the (out of stock) Stork, that appears with its baby sock to be directly competitive with Owlet’s Dream Sock.

This will all play out at the yet-to-be-announced 2024 Shareholders Meeting. This Editor notes that Politan picks its battles and is rarely defeated. Our Readers may recall that Politan swooped in on Centene Corporation in late 2021, and in short order ousted long-time directors, added new friendly ones, shook up management and forcibly retired 25+ year CEO Michael Neidorff (since deceased). Masimo’s victory over Apple may go down as either not mattering much–or that Apple will be fighting a much deeper-pocketed backer that knows how to win.

Update: It gets stranger. Masimo’s Consumer (audio) division’s brand president and general manager Joel Sietsema announced on Tuesday that he is no longer with the company. He came to Masimo through the Sound United acquisition being with them for a decade. He announced his departure on LinkedIn. It was apparently a mutual decision that preceded the current turmoil. Strata-gee 4 April

AliveCor v. Apple latest: Federal court tosses AliveCor suit on heart rate app data monopolization

February 14, 2024 | by

Apple wins one, but the other and more important AliveCor antitrust/IP cases go on. Judge Jeffrey White of the US District Court for the Northern District of California dismissed one of the many lawsuits between AliveCor and Apple. This one goes back a few years when AliveCor provided a cardiac app to the Apple Watch. The claim is that Apple’s 2018 changes in algorithms reading heart rates in the watchOS5, upgrading from the “Heart Rate Path Optimizer” algorithm (HRPO) to the “Heart Rate Neural Network” algorithm (HRNN), hurt a third-party app provider like AliveCor with their SmartRhythm app designed for the HRPO. The AliveCor argument in the 2021 lawsuit was that Apple should have made the earlier algorithms available, and that Apple violated California’s Unfair Competition Law. Apple’s argument was that the HRNN was more accurate, this was a genuine improvement that provided better data, and that third parties had no right to interfere in Apple’s design and business decisions. Since it was a summary decision, we do not know the details of Judge White’s reasoning. 

AliveCor’s full statement, provided by AliveCor, is:

AliveCor is deeply disappointed and strongly disagrees with the court’s decision to dismiss our anti-competition case and we plan to appeal. We will continue to vigorously protect our intellectual property to benefit our consumers and promote innovation. The dismissal decision does not impact AliveCor’s ongoing business; we will continue to design and provide the best portable ECG products and services to our customers.

Separately, the ITC’s findings that Apple has infringed AliveCor’s patents still stand. Both the ITC and U.S. Patent Trial and Appeal Board (PTAB) appeals will be reviewed at the United States Court of Appeals for the Federal Circuit in the coming months. In other recent developments, the PTAB recently ruled in AliveCor’s favor by instituting Inter Partes Review (IPR) of Apple’s patents and a stay of Apple’s countersuit.

We welcome any comments provided by Apple. Both AliveCor’s and Masimo’s suits go on in various courts.

Reuters, 9to5 Mac   Most recent AliveCor v. Apple coverage: spoilation split decision, ITC final determination

Peering through the cloudy crystal ball into 2024 healthcare investment and company health

January 25, 2024 | by

crystal-ballWill 2024 be the mirror image of 2023? This time last year, signs pointed to slow, steady growth after the bubble bath of 2020-early 2022 was followed by failures of tech-leveraged banks (SVB and Signature in March 2023) leading to a mid-year bust [TTA 11 Aug 23]. Some big deals kicked off the year (CVS’ Carbon Health investment, Oak Street mega-buy TTA 16 Feb 23). Then as the year went on, they were followed by sheer turmoil–huge losses and business divestitures (Cano Health, Bright Health, insurtechs like Clover and Oscar), bankruptcies and shutdowns (Babylon, Pear, Quil, OliveAI, Smile Direct, Cureatr, Rite Aid), IP lawsuits (Apple-Masimo, Apple-AliveCor, FruitStreet-Sharecare), C-levels walking the plank (Walgreens, Noom), and big layoffs nearly every week. Cigna and Humana called off merging again, perhaps because Cigna didn’t like what it saw. M&A fell to its lowest level in years and IPOs fell to zero.

To cap the year, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued new Merger Guidelines that made the M&A mountain even steeper, and will follow up this year with Pre-Merger Notification guidelines that will make that part even more costly. Both signal hard times for M&A. Add to that the overt hostility the chair of the FTC has to any kind of M&A and the weaponization of the tools government has at hand…..Even early-stage, independent companies which allegedly these agencies are trying to foster don’t catch a break. A change in the tax law hitting hardest in 2023 forces annual expenses in research and experimentation (R&E) to be amortized over five years versus one year which severely affects their financials. (Section 174 explained here)

The crystal ball promises to be more like a Magic 8 Ball this year. Other than a flurry of smaller-scale investments, a rumor of a $5 billion EHR company sale (Netsmart), and predictable layoffs in health systems, the start of the year in healthcare has been fairly (ominously?) quiet.

HealthcareFinance talked to two partners in law firm Akerman’s healthcare practice group to get their take, weaving in some findings from a PWC report: 

  • Buyer interest in acquiring practices and surgery centers
  • Partnerships on rise, for example Amazon’s One Medical with health systems 
  • Smaller hospitals in mid-America will merge as there is “safety in numbers’
  • More investment in life sciences and drug development, especially diabetes/weight loss drugs in the GLP-1 category
  • Anything around AI attracts interest

The two big factors: interest rates (the Federal Reserve has signaled no further increases, and maybe cuts in 2024) and (of course) a presidential election as well as all of the House, much of the Senate, and state gubernatorial offices.

Bubbling under this are reports of two big pending IPOs:

  • Home health, pharmacy, and eldercare services provider BrightSpring Health filed with the SEC on 3 January for a near-billion dollar IPO (publicly released on 17th). This is estimated to raise $960 million, valuing the company at about $3 billion. Common stock will debut between $15 and $18 on Nasdaq under the symbol BTSG. They are also selling 8 million tangible equity units at $50. Proceeds will go from the offerings to repay outstanding debt under various credit facilities and pay penalties associated with terminating its monitoring agreement with Kohlberg Kravis Roberts & Co. L.P. (KKR, the current owner) and Walgreens Boots Alliance. BrightSpring serves 400,000 daily patients and dispensed 34 million prescriptions in 2022. IPO timing is still to be announced. This is the second time the company has filed, abandoning its first attempt in late 2021 as the market softened in 2022. KKR is signalling an exit…will it happen this time? Release, FierceHealthcare
  • Waystar’s IPO is still pending after being announced late last year [TTA 26 Oct 23]. The RCM and payments software company delayed it to 2024 due to an uncertain market at year’s end. Reportedly the roadshows were postponed to December but there has been no confirmation that they took place. Will it happen?

Fasten your seatbelts…it may be a bumpy ride.

Breaking: appeals court continues ITC ban on Apple Watches with working pulse oximetry (updated)

January 18, 2024 | by

Breaking  US appeals court lifts temporary injunction, bans sale of new pulse oximetry-functioning Watch 9 and Ultra 2. Yesterday, the US Appeals Court for the Federal Circuit dropped the first shoe and that landed against Apple’s head. The court ruled against continuing the short-term stay against the sale and importation of new Watch 9 and Ultra 2 watches equipped with functioning pulse oximetry (blood oxygen, SpO2). That ban is now in effect. The ban is a result of the International Trade Commission’s (ITC) Limited Exclusion Order that found that Apple violated Masimo’s patents on pulse oximetry (SpO2) sensors and software that became effective on 31 December.

Apple’s workaround was to disable the pulse oximetry software for new watches they sell in Apple Stores and ship to third parties.  The hardware is still inside, but readings are disabled by the watchOS. These new versions have a /A after the model number. This workaround allows the US Customs and Border Protection (CBP)’s Exclusion Order Enforcement (EOE) branch to permit new Watch 9 and Ultra 2 watches to be imported and sold. TTA 17 Jan

Reports have confirmed that existing models that were already sold or distributed before the ban through retailers will continue to have working SpO2 software. The court decision does not require pushing a software update that disables the blood oxygen reading. These pre-ban Watches sold by third parties and on the used market do not have the /A after the model number. Other Apple Watch models that never had the pulse oximetry feature were unaffected by the ban.

Of note, the appeals court cleverly separated the Apple Watch importation from the appeal of the ITC ruling. That ‘other shoe’ is a decision on whether Apple can appeal the ITC ruling, initiating the long appeals process. That decision is pending but due shortly. See TTA 28 Dec 2023 for the timeline.

Another possible outcome is that Apple settles with Masimo at some point, an action that seems obvious, but not in Apple’s suites. CNBC, 9to5Mac has the best explanation of the model changes with commenters reflecting the split jury on whether SpO2 readings are all that critical for Watchaholics. This story is developing and will be updated.

Update 19 Jan   This Editor enjoyed reading Strate-gee’s writeup on the latest developments in Masimo v. Apple. He digs into the roots of the dispute which go quite far back, to 2022 and Apple’s poaching of Masimo employees working directly on their pulse oximetry including their chief medical officer and chief scientist. The first employee went to Apple and then started his own company. He was found to have appropriated Masimo’s trade secrets and technology. Another finding: in the Masimo letter to the appeals court (included in the article) stating that the redesign of the Apple Watch “eliminates any irreparable harm”, part of the EOE proceeding is confidential and thus the EOE decision document is not public. His speculation is that this may be a key to whether the already in circulation Watch 9 and Ultra 2 models will in future have their blood oxygen reading disabled via an Apple software update.

 

Apple removes pulse oximetry from Watches to dodge ban; AliveCor advances patent review v. Apple (two big updates!)

January 17, 2024 | by

Apple redesigns US versions of the Watch 9 and Ultra 2 to delete pulse oximetry, gains approval from US Customs and Border Protection (CBP). The CBP enforces the International Trade Commission (ITC) ban on the original Watch 9 and Ultra 2 models that found that Apple violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. The ban went into effect on 31 December but models were pulled from sale by 24 December.

While Apple’s emergency appeal of the ITC Limited Exclusion Order filed on 26 December grinds on in the US Court of Appeals for the Federal Circuit, right now the ITC ban is on a short-term stay that will be decided in the next few days. The appeals court will decide shortly whether Apple’s appeal will go forward and whether the Watch pulse oximetry version ban will be stayed until the completion of the appeal, typically another 18 months [TTA 28 Dec 2023].

Apple’s new versions of the Watch 9 and Ultra 2 without pulse oximetry skirts the ban and may be the longer term solution if the appeals court decides to uphold the ITC ban on the original models. According to HIStalk reporting Bloomberg News‘ coverage, the new versions have already been shipped to Apple Stores but not released for sale. Apple also has not disclosed whether previously sold Apple models will continue to have their pulse oximetry operative, or disabled via an update.

Masimo’s position is that Apple selling Watches without the disputed pulse oximetry is not a problem. They sent a letter to the appeals court confirming that “redesigned Watch products definitively do not contain pulse oximetry functionality” and thus are outside the scope of the import ban. In fact, “Apple’s claim that its redesigned watch does not contain pulse oximetry is a positive step toward accountability” around intellectual property rights. According to MedTechDive, Masimo’s CEO Joe Kiani is open to a settlement.

The appeals court decision on granting Apple a full appeal and stay of the ban of the watches with pulse oximetry is pending but may be decided in the next few days. It’s nice to have money to be able to redesign two flagship smartwatches, which Apple certainly does! 9to5Mac, Digital Trends

Updated 18 Jan  Federal appeals court continues import ban on Apple Watches with working pulse oximetry, Apple appeal on ITC LEO still pending

Apple’s other nemesis, ECG monitoring system AliveCor, is back with the US Patent Trial and Appeal Board (PTAB) about Apple’s patent infringements. AliveCor shared with this Editor that the PTAB is instituting an inter partes review (IPR) of two AliveCor petitions on Apple patents asserted against AliveCor: claims 11–20 of US Patent No. 10,866,619 (the ‘619 patent’) and claims 1–22 of US Patent No. 10,076,257 B2 (“the ’257 patent’). AliveCor continues to be engaged in an antitrust court action with Apple on its ECG technologies in Apple Watches in the US District Court of Northern California.

AliveCor’s statement to this Editor: 

AliveCor applauds the U.S. Patent Trial and Appeal Board (PTAB) decisions to institute Inter Partes Review (IPR) of two patents Apple meritlessly asserted against AliveCor.  These institution decisions closely follow last week’s decision by the Court in the Northern District of California to stay the underlying district court case while the PTAB analyzes the validity of Apple’s patents.  Institution decisions directed to Apple’s remaining asserted patents are expected in the coming months.

Separately, our antitrust case against Apple is proceeding in the U.S. District Court,  Northern District of California, where the judge will decide several pending motions before setting a trial date for later this year. Our cases are among many recent developments revealing the extent of Apple’s bullying.

Unlike Masimo, Apple licensed AliveCor’s ECG technology in early Apple Watches, then took action when Apple introduced its own ECG in the Apple Watch 4 in 2020.

Updated 18 Jan  The US District Court of Northern California on 17 January upheld the continued stay of Apple’s patent infringement countersuit pending the outcome of the PTAB’s Inter Partes Review (IPR) of the 257 and 619 patents. In addition, the order reveals that the PTAB has a pending decision on whether to institute IPRs on US Patent Nos. 10,270,898 and 10,568,533. Both AliveCor and Apple are required to inform the District Court of any new IPRs ordered, as well as on the current IPRs at minimum every six months to update the Court on their status and any appeals. Court order PDF

Breaking: ban on sale of Apple Watches 9 and Ultra 2 stayed by federal appeals court Wed 27 December

December 28, 2023 | by | 2 Comments

Apple Watch 9, Ultra 2 available again for sale–at least well into January, as appeals court decides. It should come as no surprise that Apple quickly appealed the US International Trade Commission (ITC) ruling of 26 October that prohibited Apple from importing either model and won a temporary stay of enforcement. The ITC ruling found that Apple in the Series 6 and later violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. ITC rulings are sent to the US president in a 60-day process that ended in no presidential veto and thus final approval on 25 December. Apple, anticipating compliance and moving in an orderly fashion, pulled both models from online sale 3 pm Eastern Time on Thursday 21 December, while Store sales ended on Christmas Eve. [TTA 21 Dec]

On Tuesday 26 December (Boxing Day), Apple filed for an emergency stay of the ban in the US Court of Appeals for the Federal Circuit which was granted almost immediately, on Wednesday 27 December. This prevents Homeland Security’s Customs and Border Protection (CBP) from enforcing the import ban until the court can consider Apple’s motion to stay the ban pending its full appeal. The timeline now, after this emergency stay, is that the ITC has until 10 January 10 to file its opposition, with Apple’s reply due on 15 January. If the court grants Apple its desire for a full appeal after that and to stay enforcement of the Limited Exclusion Order (LEO) until that appeal is decided, the enforcement timeline then typically pushes forward another 18 months. Masimo is contesting the action saying there was no emergency as Apple had already stopped selling their watches with pulse oximetry features. Apple, as the infringer on Masimo’s patents as found by the ITC, has to show the court that the stay is justified.

With the Court of Appeals ruling in place, Apple is resuming online sales today (Thursday 28 Dec) at noon Pacific Time (3pm Eastern Time).

Yet another wrinkle is that Apple has proposed a modification to both of these watches to the CBP. They are now seeking a judgment that the modified version is outside of the ITC Limited Exclusion Order. The ban also affected owners of older Apple Watches with pulse oximetry readings, as out-of-warranty watches’ hardware would not be considered repairable. 

The most legally comprehensive article on this is by Dennis Crouch at Patently-O. Bloomberg, Axios, and The Guardian. The New York Post has a backgrounder on the relationship between the current president and Masimo’s CEO, which appears to be a close one but, based on another company’s history that follows, is likely to not be pertinent to the ITC decision or approval. (This Editor notes that Apple for decades and currently has been considerably influential in government matters and business policy. It is not unusual here in the US or elsewhere for that matter that company leaders play the donation game. We eschew additional comment.)  

Apple and others’ patents–not perfect together. AliveCor is in a similar situation in its own patent legal actions with Apple: winning in an ITC patent determination approved by the White House, negative PTAB actions, then Apple appealing. AliveCor is currently engaged in an antitrust court action with Apple in the US District Court of Northern California [TTA 19 July and prior] with a decision expected in 2024. Unlike Masimo, Apple licensed AliveCor’s ECG technology in early Apple Watches, then took action when Apple introduced its own ECG in the Apple Watch 4 in 2020.

It also shows that Apple has, shall we say, a certain pattern of updates to its Watch lines that may infringe on the patents of smaller companies. Again, all Apple would need to do is license these patents and pay royalties. It might be cheaper than lawyers and lawsuits.

News roundup: Apple Watch flagships cease sale due to Masimo ITC ruling (updated); Noom, WW enter GLP-1 telehealth business; Oracle sees health side up despite Cerner drag; Cigna has multiple bidders for MA business

December 21, 2023 | by

Apple Watch Series 9 and Ultra 2 going off sale in the US this week, upholding the ITC patent ruling favoring medical device developer Masimo. On 26 October, the International Trade Commission (ITC) ruled that Apple in the Series 6 and later violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. [TTA 27 Oct] While this is awaiting presidential approval in the 60-day review period which ends on Christmas Day, Apple proactively restricted US sales of its flagship Series 9 and Ultra 2 watches which contain the blood oxygen sensors. (The SE model does not and continues to be available for direct sale.) According to 9to5Mac, online sales end on 3 pm Eastern Time on Thursday 21 December, while in-Apple Store sales stop after Christmas Eve. Of course, this won’t stop resales of existing stock through outlets like Amazon, Best Buy, and eBay. Under the ITC order, Apple cannot import either model after 25 December as the ITC issued a Limited Exclusion Order (LEO) plus a Cease and Desist Order (CDO). 

The ITC is rarely vetoed by the White House in patent actions. After that point, Apple is free to appeal in Federal District Court, which is highly likely and where the deepest pockets usually win. Also HIStalk 20 Dec and Strata-gee 21 Dec

There are other wrinkles with Masimo, though. Strata-gee.com earlier this month (13 Dec) timelines Masimo’s patent difficulties with the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruling against the very same patents, decisions upheld by the Federal Circuit Court. The PTAB also ruled against Masimo in the requested review of two Apple patents. Apple’s retaliation is to threaten lawsuits on Masimo’s new smartwatches. The icing on this messy cake is the November Delaware Chancery Court decision against Masimo, awarding $17.8 million in legal fees to activist investors/shareholders Politan Capital Management and Politan Capital NY LLC in a board fight that culminated in two seats to Politan directors.  One can sense that Apple is biding its time, though they could end all of this by negotiating a royalty to Masimo. Updated: see report on the stay effective 27 December here.

Noom and WW enter the weight loss drug-by-telehealth race. Ozempic and Wegovy, GLP-1 agonists, are increasingly popular in off-label use for obesity to produce weight loss, prescribed and managed by telehealth teams.

  • Noom, previously stressing behavioral change via app coaching direct-to-consumer, in October announced at HLTH Noom Med, a drug-focused program prescribing medications such as Saxenda (liraglutide), Wegovy (semaglutide), and the new Zepbound (tirzepatide), a dual GLP-1/G1P, all of which are injectable medications along with other GLP-1 medications such as Ozempic.
  • WW or WeightWatchers last week announced the WeightWatchers Clinic program. Via their recently acquired telehealth weight loss platform Sequence, it will offer weight loss meds and team management.  

They join Teladoc in developing weight loss programs, though Teladoc supports a physician-based care product for employers [TTA 21 April]. Both Noom and WW emphasize that member patients must qualify for the programs based on weight, BMI, and medical condition. Participants are educated through materials, coaching on behavioral management, managing appetite, and nutrition, especially in maintaining adequate protein as these medications not only induce weight loss, but also muscle loss (sarcopenia). One hopes that their teams are also knowledgeable on how these medications that slow down digestion to induce a feeling of fullness don’t mix well with surgical sedation, and that they issue cautions to patients before elective surgery. MedCityNews, FierceHealthcare, Forbes   

Noom has also replaced most of its top management since its new CEO joined in July. There’s a new CFO, chief technology officer (CTO), general counsel, two senior VPs (corporate development and partnerships, healthcare sales and services) a senior director of brand and communications, chief growth officer, chief product officer, and head of people. FierceHealthcare

Oracle Q2 results miss forecasts in rebuilding Cerner. Oracle Health, including the former Cerner, and slowing cloud growth were the culprits in their fiscal Q2 2024. Total revenue was $12.9 billion, up 5% in US dollars (4% in constant currency). Analysts expected $13.05 billion. Excluding Cerner, growth would have been 6% though Oracle did not separately break out revenue for the Cerner EHR business. Investors have noted two consecutive quarters of off-track growth and a weaker forecast for the remainder of the year. According to CEO Safra Catz and chairman Larry Ellison on the earning call, many upgrades and “modernizations” are being made to Cerner Millenium that will wrap up this FY. Half of Millenium customers will be moving over to Oracle Cloud Infrastructure (OCI) by February. They are also “rewriting” Cerner’s health and data intelligence platform, Cerner HealtheIntent, to get into population-scaled health management. ‘Transforming healthcare’ is an expensive proposition indeed. No word on the VA.  FierceHealthcare, Oracle release

And a quick follow up on Cigna’s sale of their Medicare Advantage business. Two payers so far–Health Care Service Corp. (HCSC) and Elevance–are reported to be bidding for Cigna’s MA business. The value of the business is estimated to be about $3 billion and with just under 600,000 members as of September. Both HCSC and Elevance are much larger players in MA. HCSC has over 1 million MA members in Blue Cross Blue Shield affiliates in Illinois, Texas, New Mexico, Oklahoma, and Montana. Elevance, the former Anthem, has over 2 million MA members. Bidding is expected to close this week. While MA is losing money for Cigna, they could refuse to sell if bids are unsatisfactory. FierceHealthcare, Becker’s

Breaking: ITC bans Apple Watch imports on violating Masimo blood oxygen measuring patents (updated!)

October 27, 2023 | by

Another David v. Goliath fight! The International Trade Commission (ITC) on Thursday ruled that the Apple Watch violates Masimo’s patents on light-based technology for reading blood oxygen levels (pulse oximetry). This decision by the full commission upholds January’s ruling by a judge that Apple was in violation of Masimo’s patent rights. If upheld, this would ban the importation of current Apple Watches, all of which have pulse oximetry except for the SE. The ITC issued a Limited Exclusion Order (LEO) plus a Cease and Desist Order (CDO). 

The next steps before the ban takes effect occur in the next 60 days with a presidential administration review. Presidential vetoes of the ITC are rare but not unprecedented. After the review period, Apple can take the ban to the US Court of Appeals, 

As usual there’s a war of words between the two companies:

Apple: “Masimo has wrongly attempted to use the ITC to keep a potentially lifesaving product from millions of U.S. consumers while making way for their own watch that copies Apple,” an Apple spokesperson said. “While today’s decision has no immediate impact on sales of Apple Watch, we believe it should be reversed, and will continue our efforts to appeal.”

Masimo: Chief Executive Officer Joe Kiani said the decision “sends a powerful message that even the world’s largest company is not above the law.”

Masimo primarily sells clinical monitors to hospitals, but has its own consumer products in the W1 and the upcoming Freedom watch. Reuters, 9to5Mac, Yahoo!Finance

The other David is AliveCor. Earlier, the ITC found that the Apple Watch’s ECG reading tech was in violation of AliveCor’s (the other David) patents. Apple’s appeal is pending in the US District Court of Northern California. The last word on this was in July [TTA 19 July and prior].

The Masimo story is developing and will be updated with additional information when available.

Updates   The Masimo filing dates back to 2021 and was about the Apple Watch 6, the first with pulse oximetry. That model has since been discontinued for new models Apple Watch Series 9 and Apple Watch Ultra 2 which also include blood-oxygen sensors. A previous lawsuit ended in a mistrial. Engadget

More background in Strata-Gee.com, an electronics/tech business site, on the mistrial. “Apple broke off partnership discussions with Masimo and then proceeded to hire away many of their employees to pursue adding pulse oximetry into Apple Watch on their own. It would later come out that Apple had hired a few dozen of Masimo employees.” This should sound familiar to those following the AliveCor patent infringement fight with Apple. Masimo did not win their claims of infringement on all patents listed in their lawsuit, but enough to trigger a ban.

The article also clarifies what the ITC did in using a Limited Exclusion Order (LEO) to block Apple from importing Apple Watches with the pulse oximetry technology, then adding a Cease and Desist Order (CDO) to prohibit sales from existing inventory. Again, this cannot go into effect without a presidential review signoff.

James Major, a noted patent and IP attorney of counsel at Armstrong Teasdale, opines on this on LinkedIn. His first post contains the actual filing.  His later post explains what a Section 337 action of the Tariff Act (of 1930) entails.  (Disclosure: Editor Donna worked with Mr. Major on copyright renewals for trade names on behalf of a previous company, Viterion Digital Health. Since the company had been purchased and certain renewals had been forgotten in the transition, it got sticky, but he did a great job sorting it out.)

From the Editor: This leaves Apple with the following options: drag it to Federal District Court to delay the ban, hoping that Masimo runs out of resources and fight (likely), license the technology (not likely, given the ongoing nature of this and AliveCor’s suits), or develop their own technology or software updates that skirt the patents. Do bet that this last route if taken will wind up with additional filings with the ITC.