Breaking: AliveCor wins presidential review on ITC Final Determination on Apple patent infringement

February 22, 2023 | by

Enforcement held for PTAB appeal decision. As anticipated after the International Trade Commission (ITC) decision, finding that Apple Watches infringed three AliveCor patents on ECG readings [TTA 3 Jan], the Final Determination issued 22 December 2022 has passed the 60-day mandatory presidential review and is now in effect.

The penalty in the bond assessed against Apple–$2 per watch–applies to Apple Watches with the ECG feature imported or sold during the presidential review period. It is the first Limited Exclusion Order (LEO) with a cease and desist order against Apple. However, the penalty cannot be enforced until AliveCor’s appeal of the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) ruling is decided. PTAB’s ruling in early December not only ruled that Apple did not infringe on AliveCor’s patents, but also threw out the AliveCor patents that were the basis for the infringement as unpatentable: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”) in their Apple Watches 4, 5, and 6.

The PTAB appeal is in progress. AliveCor also has a separate action against Apple through its Federal antitrust case in the Northern District of California. That will not go to trial until early 2024. AliveCor has about 170 patents, but the loss of any patents is important to a company’s IP and ultimately, funding. It’s also a clear signal to innovative companies that a David can win against a Goliath. AliveCor release

Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal

January 3, 2023 | by

David v. Goliath slugfest continues. The International Trade Commission (ITC) confirmed its Initial Determination [TTA 28 June] that Apple Watches infringed AliveCor patents on ECG readings. This Final Determination counters the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) December ruling that found not only in favor of Apple’s patents but also invalidating AliveCor’s three patents in question [TTA 8 Dec].  

The ITC’s findings come under a 60-day presidential review from 22 December. The penalty on Apple comes under a Limited Exclusion Order (LEO), a cease and desist order. It sets a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during this review period. However, enforcement of the ruling will be delayed until the review of AliveCor’s appeal of the PTAB ruling wends its way through that process in the Northern District of California, which is expected to take place in early 2024, a year from now.

A running dispute since 2020. Once upon a time, AliveCor and Apple worked together to give ECG functionality to the Apple Watch. This ended after the Apple Watch 4 incorporated ECG readings. This resulted in court actions related to patents starting in early 2021 [TTA 29 Apr 21, 9 July 21]. Apple is now up to the Watch 8, incorporating more and more cardiac and health monitoring features. AliveCor has also moved on with financing with a GE Healthcare-backed Series F this past August, the KardiaMobile 6L, and the KardiaMobile Card. As of today, it has over 170 patents.

As this Editor remarked in December, going after a rival’s patents is an often necessary but risky business that can backfire. Right now, David has moved Goliath to a draw now, with further matchups this year into next. AliveCor release, Mobihealthnews      Hat tip to Dr. Dave Albert, founder and Reader.

AliveCor loses Patent Office ruling with Apple; three patents invalidated

December 8, 2022 | by

Apple prevails in the patent infringement suit by AliveCor–and got three AliveCor heart monitoring patents invalidated as ‘unpatentable’. In the duel of patent infringement claims dating back to May 2021 between AliveCor and Apple, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) not only ruled that Apple did not infringe on AliveCor’s patents, but also threw out the AliveCor patents that were the basis for the infringement. AliveCor had sued Apple for patent infringement on their ECG technology in three US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”) in their Apple Watches 4, 5, and 6. [TTA 29 Apr 21, 9 July 21] 

The term ‘unpatentable’ is used when the PTAB deems the patent, even when granted in the past, too obvious or too general. When the PTAB finds that, they throw out the patent and it is no longer valid.

Apple of course crowed that they developed their own patents fully on their own, and not from the time when AliveCor’s ECG monitoring was incorporated into earlier Apple Watches. Apple is up to the Series 8. AliveCor has already announced it will appeal and await the pending ruling from the International Trade Commission (ITC) to block the import of Apple Watches. The ITC’s initial determination in June was positive [TTA 28 June] and AliveCor of course is ‘cautiously optimistic’ on the Final Determination due in a few days (12 December). With the PTAB’s finding, it is far less likely that the ITC will impose an import block when AliveCor’s patents have been invalidated.  9to5Mac, Mobihealthnews

AliveCor has moved forward with its KardiaMobile series, including a credit card-sized device (left), and has enjoyed substantial investment, with an August Series F (amount undisclosed) round led by GE Healthcare. 

Patent invalidation is a danger in any patent infringement lawsuit. In 2015, Bosch Healthcare, which had bought HealthHero, an early RPM platform marketed as Health Buddy, and ViTelNet, was a serial patent challenger. They went after Philips, Viterion (while owned by Bayer), both to a draw, and won against a slew of barely-out-of-the-cradle companies forgotten by nearly all of us such as Alere Health, MedApps, Waldo Health, and Express MD Solutions. Then they sued Cardiocom in 2012 with the same expectation. Except that a year later, Cardiocom was acquired by Medtronic. Deep-pocketed Medtronic fought back hard–and by 2015, the PTAB invalidated most of Bosch’s key patents. Bosch withdrew from the US market abruptly in 2015. TTA 19 June 2015, 7 September 2015 primarily about the ongoing Teladoc-Amwell dustups

Given their funding and device development, AliveCor will likely not face Bosch’s fate, but such invalidations have consequences yet to be determined and litigated. 

Smartwatches lead wearables, adoption now at 29%: Parks Associates study

October 28, 2022 | by

Health tracking and users are leading the way into smartwatch adoption and wearables popularity. In just one year, (Q2 2020 to Q2 2021), smartwatch ownership increased 13 points from 16 to 29% of US households. Fitness trackers, which once predominated, increased five points to 23%, while GPS sport watches grew four points to 11% in US households.

Overall:

  • Smartwatches are dominated by the Apple Watch (1st left), with Samsung’s devices a distant second.
  • Smartwatch owners are particularly likely to own and use other connected health products, with these consumers reporting owning an average of 6.8 devices (including their smartwatch)
  • Most people buy their smartwatches through ecommerce channels–42%–but 30% still use traditional retail. (15% are gifts!)
  • Intent to purchase in the next six months has rocketed from 18% to 45%
  • Apple and Samsung lead all wearable brands under consideration. Curiously, pioneers Fitbit and Garmin are ranked below LG and Sony, which no longer offer wearables. (Fitbit–2nd left–and Garmin need to do some marketing)
  • Fitness trackers/bands hold their own, but GPS sport watches are the weakest of the three categories. Current owners are most likely to seek a new model, with 88% of owners reporting intention to purchase.
  • Most of the intenders are “very likely” to purchase add-on subscriptions for their watch, such as cellular plans (69%) and at-home fitness programs (47%), as long as they are at $10/month. This overlaps into cellular phone providers who need to keep these subscriptions inexpensive.

Parks Associates surveys every quarter 10,000 U.S broadband households, with additional surveys throughout the year. The results represent the national demographics for US broadband households, which are 88% of all US households. To read the full survey results, go to Parks Associates’ survey page.

US International Trade Commission initial determination: Apple infringed AliveCor’s patents (updated)

June 28, 2022 | by

If affirmed, a David versus Goliath win. AliveCor, the developer of the KardiaMobile ECG devices, announced late today that Administrative Law Judge (ALJ) Cameron Elliot of the US International Trade Commission (ITC) issued an Initial Determination that Apple infringed certain AliveCor technology patents. If affirmed by the full ITC in a Final Determination by 26 October (!), it could lead to an exclusion order barring the importation of certain Apple devices infringing on AliveCor patents from the US.

The initial complaint was filed in May 2021 [TTA 29 April] concerning Apple’s infringement in the Apple Watch 4, 5, and 6 of three AliveCor ECG technology US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”). Last February, AliveCor successfully moved with the ITC to have the investigation terminated on certain claims on the three patents, but a considerable number remained. This is what ITC terms an “unfair import” or Section 337 investigation. These regard intellectual property rights, including “allegations of patent infringement and trademark infringement by imported goods.”

Updated for links: AliveCor press release, ITC Public Notice which details what parts of what patents have been infringed. Both the 731 and the 941 patents have been found to be infringed under Section 337. The 499 patent has not been violated. This Editor will assume we have to wait till October for any exclusion orders.

Weekend review: FDA clears Apple Watch ‘AFib History’, OS9 adds health features; Amwell’s new CMO; 2M records breached at New England provider, largest this year

June 10, 2022 | by

Apple Watch adding first-ever ‘AFib History’ in watchOS 9 software release. Announced 6 June, Apple received their FDA 510(k) clearance for this new feature which adds on to the existing ECG app and irregular rhythm notification. The History feature includes an estimate of how frequently a user’s heart rhythm shows signs of atrial fibrillation, including additional weekly notifications to understand and track this on a printable PDF. According to their release, users can view a detailed history in the Health app, including lifestyle factors that may influence AFib, like sleep, alcohol consumption, and exercise, which can be downloaded and printed.

Other health-related features on the watchOS9 release include:

  • Medications app for managing medications, vitamins, and supplements, including a medications list, schedules and reminders, and directly view medication information in the Health app
  • Sleep Insights, an add-on to the existing sleep tracking that informs users of sleep stages. Using signals from the accelerometer and heart rate sensor, it will detect and track when users are in REM, core, or deep sleep.

Apple release 6 June, FierceHealthcare

Amwell names new chief medical officer. Carrie Nelson will be working with payer and provider organizations in care delivery from Amwell’s new platform, Converge. In addition, she will be heading up the Amwell Medical Group, their clinical partner. Dr. Nelson was formerly Advocate Aurora Health’s senior vice president and CMO for Population Health and Health Outcomes, where she was also chief clinical officer for Advocate Physician Partners, their value-based care physician group. Amwell is transitioning practices from its prior platforms and needs to maintain their presence with both groups as many are finding alternative telehealth systems. Amwell release, Healthcare Dive

And what week wouldn’t be complete without a massive healthcare data breach? The leading event so far this year took place over two weeks in March at 60 healthcare facilities affiliated with Massachusetts-based Shields Health Care Group. While it was only 7 to 21 March and discovered 28 March, apparently the quaintly-titled ‘unknown actor’ was able to compromise data. The investigation by Shields and Federal and state regulators is ongoing as to what data was accessed and taken; to date, there is no evidence to indicate that any information from this incident was used to commit identity theft or fraud. The difference in breaches between now and the past is how rapidly it’s discovered.  Shields Health notice, Healthcare Dive

Is healthcare too much for Big Tech’s Google and Apple? Look at the track record. And David Feinberg’s $34M Cerner package.

August 24, 2021 | by

With Google scattering Google Health to the four winds of the organization--the heck with what employees recruited for Health think of being reorg’d to, say, Maps or YouTube and falling through the corporate rabbit hole–more detail has leaked of Apple’s struggles. This time, on the scaleback list (a/k/a chopping block) is Health Habit. It’s an app in the Apple Store that connects users with AC Wellness, a doctor’s group in Cupertino, California. The ‘eligible participants’ are restricted to Apple employees. From the app site, they can check weight, nutrition, blood pressure, and schedule wellness checks. It seems to be the typical ‘skunk works’ project that’s not ready for prime time, but its public fate seems to be poorly timed and simultaneously, overblown because they are–well–Apple. 

Bottom line, is healthcare once again proving rather resistant to being leveraged by technological solutions? Those of us who go back to the Stone Age of health tech, or those of us who joined in the Iron and Bronze Ages, remember when you couldn’t get into a conference cocktail party without a “wellness” app. (You say you’re in behavioral and remote patient monitoring for older adults? Oh, look! A squirrel!)

Microsoft was going to dominate consumer health with their HealthVault for personal health records (PHRs). We know how that turned out–dead apps, Fitbit an also-ran bought, Pebble and Misfit going to the drawer of failed toys, Jawbone t-boning plus Intel and Basis written off in 2017, and HealthVault unlamentedly put out with the trash at the end of 2019. Oh yes, there was an earlier Google Health for PHRs, which died with a whimper back in 2012 or so.

The press releases crow about Big Tech’s mastery of complexity, yet going off on their own without partners–or even with partners–never seems to work. In the industry, it makes for a few good articles and the usual rocket launching at places like Forbes, but the pros tend to treat it with a shrug and pull out a competitive plan. Glen Tullman, founder of Livongo who will never have to worry about paying for chateaubriand for two for the next billion years or so, stated the obvious when he said that patients cared about the overall experience, not the tech.

Speaking of experience, Amazon Care promises the best for its employees and enterprise accounts–a one-minute telehealth connection, a mobile clinician if needed within the hour, and drugs at the door in two hours. All with direct pay. This has met with skepticism from telehealth giants like Teladoc and Amwell with established corporate bases. There’s also CVS Health and Walgreens. The Editor has opined that care isn’t Amazon’s game at all–it’s accumulating and owning national healthcare data on Amazon Care and Pharmacy users that is far more valuable than whatever is spent on providing care and services [TTA 16 June]. Will Amazon really be able to pull it off?

Paddy Padmanabhan, the author of Healthcare Digital Transformation, lists a few more reasons It’s Too Hard For Big Tech In Healthcare in his HealthcareITNews article here….

  • Healthcare is a part-time job for Big Tech
  • Big tech firms want to solve the healthcare problem by themselves
  • Selling technology is not the same as selling healthcare services

…but holds out some hope that the initial success of “digital-first and virtual-first providers of healthcare emerging as challengers” will point the way for them.

And speaking of Google Health and former employees, Cerner’s necessary SEC disclosure today of new CEO and president David Feinberg, MD’s compensation package was sure to create some talk in Googleville among his now-scattered team. $34.5 million over the next 15 months is structured as follows:

  • $900,000 base salary
  • a target cash bonus of $1.35 million
  • a one-time cash bonus of $375,000 stock
  • $13.5 million in Cerner’s restricted shares for 2022
  • $3.375 million in stock shares for the fourth quarter of 2021
  • a new hire award of $15 million in restricted stock shares to offset his equity loss with Google. 

Whew! Becker’s HealthIT

News roundup: AliveCor’s latest FDA clearance plus antitrust vs. Apple, VRI on the market, Walgreens’ ‘tech-enabled future’ indefinite plus VillageMD status, monthly telehealth usage drops 12.5%

July 9, 2021 | by

AliveCor disclosed its latest FDA 510(k) clearance for the KardiaMobile 6L, for calculation of patients’ QTc interval by the patient remotely or in the office with a physician or other clinician. QTc interval is, for those of us who aren’t cardiologists, is the total time from ventricular depolarization to complete repolarization. If too long (prolongation) or too short (congenital short) for the heart rate, it can indicate a dangerous ventricular arrhythmia or atrial or ventricular fibrillation. The manual measurement takes 30 seconds. AliveCor also has clearance on software (InstantQT) that measures QT intervals quickly and accurately to detect potentially dangerous QT prolongations in patients. Prolongations can be triggered by medications including anti-arrythmia drugs, anti-fungals, antibiotics, and some psychiatric drugs. AliveCor release. In other recent news, in June they acquired CardioLabs, a monitoring and cardiac diagnostic service provider based in Tennessee, to expand their clinical servies. Release.  

And in David Sues Goliath–Again–News, AliveCor also filed, in that quiet week right before Memorial Day, a Federal antitrust suit in the Northern District of California. This lawsuit is over Apple’s exclusion of other heartrate analysis providers from the Apple Watch, harming AliveCor and consumers, and seeks damages plus an injunction to cease the exclusion. Release  This is in addition to their US International Trade Commission (ITC) complaint on infringement of AliveCor patents held for heart monitoring on the Apple Watch 4, 5, and 6. That seeks to bar importation of Apple Watches [TTA 29 Apr]. No update on that so far. 

‘Insider’ report: VRI on the market. PERS Insider, our newly discovered source for news about the emergency response device market, reported on 22 June that VRI, a PERS and remote patient monitoring provider, is up for sale. It has been majority-owned by Pamlico Capital, a private equity company, since 2014. VRI does not sell direct to consumer but concentrates on health insurance, government programs, and other B2B through its dealer network. No reasons for sale given, but with all things telehealth and most things remote healthtech fetching hefty sums post-pandemic, perhaps Pamlico senses a fortuitous time to test the waters for an exit. Article. (Subscribe here to their weekly free letter)

Walgreens Boots Alliance’s new CEO promises a ‘tech-enabled’ future for the chain, sans details. The incoming CEO, Rosalind Brewer, fresh from her COO position at Starbucks, on WBA’s Q3 earnings call mentioned a buildout of a “previously communicated tech-enabled healthcare initiative” but no further information, as still reviewing the company. Stefano Pessina has retired from the long-held CEO position, but retains the executive chair title in addition to being WBA’s largest individual shareholder. Forbes’ breathless report. More to the profit point, the latest on Walgreens and VillageMD’s full-service Village Medical practices at Walgreens locations: 29 new locations in Houston, Austin and El Paso, Texas this year, staying on track for 600 primary care practices in more than 30 markets over next four years. Business Wire

National telehealth usage dips to 4.9% of US claims in April, a 12.5% drop from March. Analyzing regional and national insurance claims data, non-profit health analytics company FAIR Health in its monthly report tracks telehealth receding as patients return to in-person care. Telehealth is now dominated by mental health procedure codes, accounting for 58.65% of diagnoses, with all other conditions at 3% or lower. Regionally, the Northeast is even higher at 64.2% and the Midwest above 69%. Monthly National report, Monthly Regional Tracker page

David sues Goliath: AliveCor claims patent infringement by Apple–ITC filing requests bar on Apple Watch US importation

April 29, 2021 | by | 1 Comment

Slingshot battle! AliveCor, developer of the Kardia Mobile electrocardiogram (ECG) and connected heart rhythm devices, filed a complaint with the US International Trade Commission (ITC) alleging Apple’s infringement of three AliveCor ECG technology patents for the Apple Watch 4, 5, and 6. The filing seeks to bar the importation of Apple Watches into the US and their sale.

According to AliveCor’s carefully worded release, their filing in the ITC “is one step, among others, AliveCor is taking to obtain relief for Apple’s intentional copying of AliveCor’s patented technology—including the ability to take an ECG reading on the Apple Watch, and to perform heartrate analysis—as well as Apple’s efforts to eliminate AliveCor as competition in the heartrate analysis market for the Apple Watch.”

This follows on the first shoe–AliveCor’s December lawsuit, filed in the US District Court for the Western District of Texas, alleging that the Apple Watch 4, 5, and 6 infringed on the same patents. The timing was interesting, as FDA cleared the latest update of the Apple Watch’s ECG monitoring at about the same time [TTA 10 Dec 2020]. In November, AliveCor cleared a Series E of $65 million.

The irony is that in 2017, the KardiaBand was the first FDA-cleared medical device accessory for Apple Watch. It was an ECG-reader that clipped onto the watch. AliveCor pulled it from the market after Apple introduced its own ECG feature in the Apple Watch 4.

AliveCor has their entire business riding on this. The mass-market Kardia Mobile, their six-lead medical-grade KardiaMobile 6L, and their KardiaCare platform with monitoring and evaluations are their business, unlike Apple for which ECG is only a feature.  Mobihealthnews, FierceHealthcare, MDDIOnline

News roundup: Cera hits £89.5M revenues, Alcove Carephone in new elder housing, Everlywell home test kits raise $179M; FDA clears Lucira’s all-in-one COVID test kit, Apple Watch new ECG feature

December 10, 2020 | by

Farringdon, London-based Cera announced a high point in its revenues of £89.5 million ($120 million) since their 2016 launch. While it is primarily a home care company d/b/a-ing under Cera Care (and seeks to hire an additional 5,000 staff, mostly professional carers), we noted back in March their £52 million ($70 million) raise and the launch of SmartCare, a sensor-based analytics platform that uses machine learning and data analytics in real-time on behaviors to personalize care and detect health risks with a reported 93 percent accuracy. Cera also has a proprietary app to connect families with Cera on visits and progress. Unfortunately the Cera website is singularly uninformative on company news and SmartCare. Mobihealthnews

Alcove is partnering with Cornell Court in Saffron Waldon, Essex, an extra-care community developed and run by L&Q Living, to fit out apartments with their in-residence Carephone tablet. Having the access to the tablet, residents can easily initiate a group video call with family members, as well as attend virtual care and therapy sessions and activities including bingo and exercise classes. There is also access to a ‘virtual concierge’. The combination of onsite services and the Carephone access helps with resident independence. All helpful as the UK remains on a non-virtual lockdown in most places and Christmas looks distinctly un-festive this year, especially for older adults. Local Authority Building & Maintenance (LABM) Online.

COVID-19 has certainly been a boom of a boon for at-home testing companies.

  • Everlywell just raised a hefty Series D of $179 million. They market and process over 30 FDA-cleared kits, including (of course) symptomatic COVID-19 (SARS-CoV-2, lower nasal swab) with a follow up from the lab in 24-48 hours via their app coupled with a telehealth consult. Other kits include thyroid, indoor/outdoor and food allergies, and hepatitis C, at prices ranging from $49 to a comprehensive food sensitivity test at $259. Prediction: Everlywell and similar companies will be 2021’s 23andMe/Ancestry.com.  Fierce Biotech
  • An equally intriguing ‘home run’? FDA cleared the first ‘all-in-one’ home test for COVID-19 under an EUA (Emergency Use Authorization). The Lucira Health molecular test from a nasal swab sample is completed by a battery-powered handheld unit that includes all the reagents needed to process the test. The unit then shows the result with a green light for positive or negative. Average time: 2 minutes. Molecular tests are more sensitive and accurate than the current quick tests of antigens. Go-to-market of the single-use test kit is expected early spring 2021, at a cost of $50. The by-prescription test can also be performed in point of care settings. The company will be filing early next year to have as an option prescription via telehealth. Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale participated in the trials and will be first on distribution. Fierce Biotech, Lucira press release, FDA release

Remember when any burp from Apple was Major News, breathlessly awaited? Now ho-hum. FDA cleared the latest update of the Apple Watch’s ECG monitoring. Now the feature enables heart rate detection up to 150 beats per minute and adds a classification category called A-Fib with high heart rate. The Apple Watch has been used in some studies to monitor for atrial fibrillation. No release date is set for the watch. However, AliveCor is suing Apple on patent infringement of three patents, from the Apple Watch Series 4 and later devices, so stand by. Mobilhealthnews

En Vogue: smart clothing and wearables to track COVID spread and progression

July 29, 2020 | by

Wearables and smart clothing are having a ‘moment’ in the tracking of COVID symptoms and spread. After TTA noted Nanowear’s clinical trial with two major New York metro health systems last week, both POLITICO and Mobihealthnews catalogued additional trials and uses of innovative clothing and devices for detection: 

  • Apple watches and Fitbits
  • Oura rings (!) by the NBA to detect temperature and heart rate–at about $300 and up
  • Northwestern University and Shirley Ryan AbilityLab have developed a sensor that adheres in the visible dip at the base of the throat to monitor respiratory symptoms
  • Tufts University’s sweat sensor embedded in clothing, to analyze elements in perspiration such as electrolytes (sodium and ammonium ions), metabolites (lactate) and acidity (pH). NPJ Flexible Electronics
  • Paris-based Chronolife, which debuted the Nexkin smart T-shirt in December. It monitors heart rate, abdominal and thoracic breathing, body temperature, physical activity, and pulmonary impedance.

Part of the problem of wearable adoption is that without a specific ‘reason why’, wearables haven’t been all that compelling for the mainstream market beyond the trendy and pricey Apple Watch. Wearables have tried corporate wellness programs that almost give away the devices with the promise of lowering health costs long term. Venture funding (see the POLITICO chart) has been flowing into these companies for a decade. But in the eyes of many, wearables are a solution without a clear and compelling problem. COVID may resolve that.

News, events roundup: FDA clears AliveCor’s first 6 lead ECG, Jawbone Health rises from ashes, Let’s Get Checked’s $30M check, Health Wildcatters’ $35M ‘how to’ breakfast

May 14, 2019 | by

AliveCor receives FDA clearance for KardiaMobile 6L, the first FDA-cleared personal 6-lead device. From the AliveCor release, the description: “In addition to the two electrodes on the top of the device, there is one additional electrode on the bottom. The user places her thumbs on each of the two top electrodes, and places the bottom electrode on her left knee or ankle. This formation, known in cardiology as the Einthoven Triangle, allows cardiologists to view electrical activity in the heart from six perspectives or “leads.”” The information is sent to the mobile device’s software including KardiaAI bradycardia and tachycardia detection features cleared recently for the single-lead KardiaBand, as well as deeper information into arrhythmias. The single-lead ECG space that AliveCor pioneered with first their snap-on then the KardiaBand is now crowded with the Apple Watch, Withings, and numerous others. It’s a big step forward for the company. AliveCor has opened pre-orders now at $149, to be delivered starting in June. Hat tip to co-founder Dr. Dave Albert. 9to5Mac, Biospace (release), Mobihealthnews. 

Save Your Jawbones, the Founder Rises Again. Yes, Jawbone founder Hosain Rahman just raised $64.5 million for a new company. The new outfit, dubbed Jawbone Health, will offer a “personalized subscription service where we take all of this continuous health data about you and we combine that with a lot of machine intelligence . . .” to prevent avoidable diseases. After having burnt to a crisp $1 billion over 10 years on wireless speakers and fitness bands, again Mr. Rahman goes into territory which isn’t exactly unique with the footprints of the aforementioned Apple Watches, Withings, Spry Health’s Loop, EarlySense, etc. But hey,  SignalFire and Refactor Capital in the Bay Area, Polymath Ventures and Meraas in Dubai like his style. Even TechCrunch is arching an eyebrow.

Let’s Get Checked checks in with $30 million raise. This NYC-based direct-to-home supplier and manufacturer of in-home test kits raised a $30 million Series B from Leerink Transformation Partners, Qiming Venture Partners USA, and Optum Ventures after last year’s $10 million Series A. Customers can order in-state physician-approved laboratory tests via LetsGetChecked.com or through partner retailers, including CVS, Walmart, Pharmaca, and McKesson online stores, with delivery in 1-2 days. Tests covering wellness, men’s and women’s health are processed by CLIA-certified reference labs with results sent to a secure online account in 2-5 days, with the customer referred to in-state physicians for interpretation of results and further action if needed. PrivaPath Diagnostics markets in the US, Canada, Ireland, and Europe. Release

Speaking of raising money, how about $35 million for your med device startup? Health Wildcatters is hosting one of their Pulse Health Startup Education Series breakfasts (7.30-9am) in Dallas on Tuesday 21 May with main speaker Ken Nelson from Bardy Diagnostics, which just had a $35.5 million Series B, presumably letting everyone in on the secret. Registration and more information here.

Short takes: Livongo buys myStrength, Apple Watch cozies with insurers, Lively hears telehealth and $16 million

January 31, 2019 | by

Livongo gets behaviorally stronger with myStrength. Extending from their base in diabetes and chronic disease management into behavioral health, Livongo made a logical extension with early-stage behavioral health company myStrength. A large percentage of those with chronic conditions are also struggling with a behavioral health issue–Livongo cites 20 percent but in this Editor’s opinion, the estimate is low. Both Livongo and myStrength have been very successful in the payment game, with both companies achieving payment and reimbursement by employers, insurers, health systems, and state/Federal payers. The other factor is that employers and payers want single, integrated platforms for wellness and disease management. Livongo last year bought Retrofit for its weight management program. Competitor Omada Health recently acquired the behavioral health technology of defunct Lantern. MedCityNews, Fortune, Livongo release

Apple Watch wastes no time in partnering with insurers. Or vice versa! Confirming that Apple Watch’s growth strategy hinges heavily on health via its new features are fresh agreements with Aetna/CVS Health and a rumored reach into three Medicare Advantage plans. The Aetna partnership is with an app called Attain, which blends Apple Watch activity tracking data with users’ health history to create personalized programs. The program is limited to about 250,000 slots plus additional slots for employer plans, and will debut this spring. Late last year, United HealthCare announced Apple Watches would be added to existing wellness program called Motion and their Rally platform. Both Aetna and United have tiered payment programs for the watches, with United adding a HSA reward. For Medicare Advantage plans, Apple is rumored that they will subsidize the watch for use as a health tracker and coach. FierceMobileHealthcare 30 Jan (Aetna), 14 Nov 18 (UHC), and 29 Jan (Medicare Advantage).

Lively adds telehealth to hearing assistance. Lively’s mobile-connected, direct to consumer hearing aids are adding more telehealth features such as remote tuning, virtual video consults with an audiologist, and an online hearing assessment/uploading audiogram for assessment. The NYC-based company also announced closing on a $16 million seed/Series A fundraising round led by Declaration Capital with participation from Tiger Management. There are an estimated 35 million Americans with hearing loss in a $10bn annual market. Hearing aids are rapidly adding digital and DTC features–others in the field are Eargo and ReSound. Lively release, AlleyWatch, Mobihealthnews. (Lively is not to be confused with Lively!, acquired by GreatCall two years ago)

Apple Watch, Zimmer Biomet in clinical trial for monitoring hip and knee replacements

October 18, 2018 | by

imageZimmer Biomet, a musculoskeletal medical device company, is partnering with Apple to use the Apple Watch with an iPhone 6s and above in tracking the pre-surgery and post-operative recovery process for patients with hip and knee replacements. Zimmer is using the mymobility app developed with Apple to track patient-reported feedback, provide patient education and guidance, and share continuous health and activity sensor-based data with care teams. The aim is to improve the standard of care and patient outcomes after these surgeries.

The mymobility Clinical Study started on 15 October and may enroll up to 10,000 patients with 16 corresponding healthcare facilities including academic health systems, hospitals, and orthopedic surgery centers/practices. No length or end date for the study has been disclosed. 

A positive outcome leveraging patient engagement and providing continuous detailed clinical tracking data could have major significance. There are over 1 million hip and knee orthopedic replacements in the US annually, which is expected to increase to 3.5 million by 2035. The average cost of a hip or knee replacement is estimated at about $31,000, varying widely by region, based on a 2015 Blue Cross Blue Shield Association study. Post-surgery complications are common enough so that Medicare.gov tracks them through Hospital Compare.

According to Zimmer, “the mymobility app provides instruction and opportunities for enhanced engagement between the patient and healthcare provider. This mobile application is designed to work with the Apple Watch® wearable companion to remind patients to check their smartphone application daily, to read pre-planned and timed educational information, perform tasks, and complete assigned exercises; understanding their condition and care plan gives patients the ability to actively participate in optimizing their surgical outcome.” For the clinician, it is a communication tool between the patient and care team. “Surgeons use a clinician dashboard to monitor the threshold values and actively observe progress throughout each patient’s journey. Through the adoption of multifunctional sensor technology in the form of a wearable companion on the wrist, mymobility provides the potential to identify metrics that may permit further refinement of pre and postsurgical care.”

Healthcare Dive, Zimmer Biomet release, Zimmer mymobility study website

The Apple Watch, ECG and fall detection–a trend too far?

October 4, 2018 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/10/apple-watch-series-4-elektrokardiogram.jpg” thumb_width=”125″ /]Mid-September’s Apple Fans kvelled about the Apple Watch Series 4 debut. Much was made in the health tech press of Apple’s rapid FDA clearance and the symbolism of their further moves into medical devices with the Series 4 addition of a built-in atrial fibrillation-detecting algorithm and an ECG, along with fall detection via the new accelerometer and gyroscope.

This latter feature is significant to our Readers, but judging from Apple’s marketing and the press, hardly an appealing Unique Selling Proposition to the Apple FanBoys’n’Girls who tend to be about 35 or wannabe. The website touts the ECG as a performance feature, a ‘guardian and guru’ topping all the activity, working out, and kickboxing you’re doing. It positions the fall detection and Emergency SOS in the context of safety during or after hard working out or an accident. It then calls 911 (cellular), notifies your emergency contacts, sends your current location, and displays your Medical ID badge on the screen for emergency personnel, which may not endear its users to fire and police departments. 

Laurie Orlov in her latest Age In Place Tech article points out the disconnect between the fall risk population of those aged 70+ and the disabled versus the actual propensity (and fisc) to buy an Apple Gizmo at $400+. PewInternet’s survey found that 46 percent of those over 65 actually own a smartphone, though this Editor believes that 1) much less than 50 percent are Apple and 2) most smartphone features beyond the basic remain a mystery to many. (Where store helpers, children, and grandchildren come in!)

Selling to older adults is obviously not the way that Apple is going, but there may be a subset of ‘young affluent old’ who want to sport an Apple Watch and also cover themselves for their cardiac or fall risk. (Or have children who buy it.) This is likely a sliver of a subset of the mobile PERS market, which is surprisingly small–only 20 percent of the total PERS market. But monitoring centers–doubtful, despite it being lucrative for GreatCall.

Rounding up the roundups in health tech and digital health for 2017; looking forward to 2018’s Nitty-Gritty

December 29, 2017 | by | 2 Comments

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”100″ /]Our Editors will be lassoing our thoughts for what happened in 2017 and looking forward to 2018 in several articles. So let’s get started! Happy Trails!

2017’s digital health M&A is well-covered by Jonah Comstock’s Mobihealthnews overview. In this aggregation, the M&A trends to be seen are 1) merging of services that are rather alike (e.g. two diabetes app/education or telehealth/telemedicine providers) to buy market share, 2) services that complement each other by being similar but with strengths in different markets or broaden capabilities (Teladoc and Best Doctors, GlobalMed and TreatMD), 3) fill a gap in a portfolio (Philips‘ various acquisitions), or 4) payers trying yet again to cement themselves into digital health, which has had a checkered record indeed. This consolidation is to be expected in a fluid and relatively early stage environment.

In this roundup, we miss the telecom moves of prior years, most of which have misfired. WebMD, once an acquirer, once on the ropes, is being acquired into a fully corporate info provider structure with its pending acquisition by KKR’s Internet Brands, an information SaaS/web hoster in multiple verticals. This points to the commodification of healthcare information. 

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/canary-in-the-coal-mine.jpgw595.jpeg” thumb_width=”150″ /]Love that canary! We have a paradigm breaker in the pending CVS-Aetna merger into the very structure of how healthcare can be made more convenient, delivered, billed, and paid for–if it is approved and not challenged, which is a very real possibility. Over the next two years, if this works, look for supermarkets to get into the healthcare business. Payers, drug stores, and retailers have few places to go. The worldwide wild card: Walgreens Boots. Start with our article here and move to our previous articles linked at the end.

US telehealth and telemedicine’s march towards reimbursement and parity payment continues. See our article on the CCHP roundup and policy paper (for the most stalwart of wonks only). Another major change in the US is payment for more services under Medicare, issued in early November by the Centers for Medicare and Medicaid Services (CMS) in its Final Rule for the 2018 Medicare Physician Fee Schedule. This also increases payment to nearly $60 per month for remote patient monitoring, which will help struggling RPM providers. Not quite a stride, but less of a stumble for the Grizzled Survivors. MedCityNews

In the UK, our friends at The King’s Fund have rounded up their most popular content of 2017 here. Newer models of telehealth and telemedicine such as Babylon Health and PushDoctor continue to struggle to find a place in the national structure. (Babylon’s challenge to the CQC was dropped before Christmas at their cost of £11,000 in High Court costs.) Judging from our Tender Alerts, compared to the US, telecare integration into housing is far ahead for those most in need especially in support at home. Yet there are glaring disparities due to funding–witness the national scandal of NHS Kernow withdrawing telehealth from local residents earlier this year [TTA coverage here]. This Editor is pleased to report that as of 5 December, NHS Kernow’s Governing Body has approved plans to retain and reconfigure Telehealth services, working in partnership with the provider Cornwall Partnership NHS Foundation Trust (CFT). Their notice is here.

More UK roundups are available on Digital Health News: 2017 review, most read stories, and cybersecurity predictions for 2018. David Doherty’s compiled a group of the major international health tech events for 2018 over at 3G Doctor. Which reminds this Editor to tell him to list #MedMo18 November 29-30 in NYC and that he might want to consider updating the name to 5G Doctor to mark the transition over to 5G wireless service advancing in 2018.

Data breaches continue to be a worry. The Protenus/DataBreaches.net roundup for November continues the breach a day trend. The largest breach they detected was of over 16,000 patient records at the Hackensack Sleep and Pulmonary Center in New Jersey. The monthly total was almost 84,000 records, a low compared to the prior few months, but there may be some reporting shifting into December. Protenus blog, MedCityNews

And perhaps there’s a future for wearables, in the watch form. The Apple Watch’s disconnecting from the phone (and the slowness of older models) has led to companies like AliveCor’s KardiaBand EKG (ECG) providing add-ons to the watch. Apple is trying to develop its own non-invasive blood glucose monitor, with Alphabet’s (Google) Verily Study Watch in test having sensors that can collect data on heart rate, gait and skin temperature. More here from CNBC on Big Tech and healthcare, Apple’s wearables.

Telehealth saves lives, as an Australian nurse at an isolated Coral Bay clinic found out. He hooked himself up to the ECG machine and dialed into the Emergency Telehealth Service (ETS). With assistance from volunteers, he was able to medicate himself with clotbusters until the Royal Flying Doctor Service transferred him to a Perth hospital. Now if he had a KardiaBand….WAToday.com.au  Hat tip to Mike Clark

This Editor’s parting words for 2017 will be right down to the Real Nitty-Gritty, so read on!: (more…)