TTA’s Blooming Spring 5: Hinge Health’s IPO, 23andMe bought by Regeneron, sans Lemonaid, WeightWatchers’ future, debuts of Smarter Technologies and Fuze Health, VA EHR update, more!

May 23, 2025 | by

 

23 May 2025

The major news this week was the Hinge Health IPO, the first for digital health in two years–but the downside was that it was at a lower valuation. Denouements abounded with most 23andMe genetic assets bought by Regeneron, without a drink of Lemonaid. WeightWatchers’ time may have passed, new heads for Calibrate and Oak Street, and two more ‘arranged marriages’, Smarter Technologies and Fuze Health. An update on the VA EHRM in the budget. Masimo’s recovering, as is Ted of Strata-gee. 

Remember our soldiers, sailors, airmen, and Marines who have passed on this Memorial Day. Our Monday newsletter will be on Tuesday.

News roundup 22 May: an inflight ‘save’ and AliveCor’s KardiaMobile, rolling out the VA/Oracle EHR in ‘waves’, Fuze Health formed from LetsGetChecked/Truepill, hacking and ransomware 92% of PHI data breaches (A renaming of a 2024 ‘arranged marriage’–can it be saved?)

News roundup: Hinge Health public @$32/share, lower valuation. Is WeightWatchers game over? Calibrate replaces CEO, new prez for Oak Street, NMC gets ‘Smarter’ rolling up 3 portfolio companies, another splash of investor ‘cold water’ (The first health tech IPO in 2 years and ‘smushing’ when they can’t)

Update: Masimo’s website status and an analysis of the Sound United sale (Getting up and running post-attack, but what happened?)

23andMe sold to Regeneron for $256M in court-supervised bankruptcy, sans Lemonaid. And is it worth it? (We come up with a number, it’s likely)

From last week: UnitedHealth Group changed out CEOs suddenly. The new one is a surprising ‘blast from the profitable past’ but that didn’t stop Mr. Market from taking the stock down down down. Another blast involves Elizabeth Holmes’ partner Billy Evans fronting a diagnostic testing- in-a-box startup.”Surprise, surprise!” No surprise that Holmes lost her appeal of an appeal–nor Omada Health filing for an IPO. Unfortunately, our investigator on all things Masimo met his own surprise walking on a sunny day–fortunately, Ted’s on the mend. More about BCIs with Apple integration, a chronic pain management startup, Parkinson’s data, two good raises, and what payers pay to keep their execs safe.

Short takes: Synchron BCI integrates with Apple devices, Shields Health partners with Duke on specialty pharmacy, raises for Cohere Health, Olio (More BCI action with Apple getting into it)

Theranos’ revenge? Holmes’ partner Billy Evans founds a startup for diagnostic testing, denies it is ‘Theranos 2.0’; Holmes loses Federal rehearing appeal. (Is Holmes advising long distance? Letters from a Texas Jail?)

News roundup: Omada Health files for IPO, UPMC-Redesign partner on chronic pain management, OK and PA AGs warn 23andMe users to delete data, Verily to build Parkinson’s dataset, what payers paid for exec security (Omada follows Hinge. But the last is surprising–between a lot and a little)

This just in: UnitedHealth Group CEO Andrew Witty steps down immediately, replaced by former CEO Stephen Hemsley (updated 15 May) (UHG may change out CEOs, but continues to be hammered by Mr. Market)

Best wishes to Strata-gee’s Ted Green on a fast recovery! (Ted, our ace Masimo investigator, was put rather suddenly in a bad place…use your eyes when you drive!)

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Update: Masimo’s website status and an analysis of the Sound United sale

May 22, 2025 | by

Things are apparently a lot more together for Masimo online. Their website structure has settled down since their cyberattack at the end of April brought down their websites, then by 6 and 13 May, a confusing and partial restoration [TTA 7 May]:

  • A new Masimo site at https://www.masimo.com/ that leads with Professional Health with a tab at the top for Consumer Health. Professional Health opens a series of sub-tabs leading with Technology and Products. A tab for Masimo Audio does not appear unless you open Consumer Health, leading to pages for their brands Bowers & Wilkins, Denon, and others. A new feature is at the top right with a dropdown for multiple languages/countries, including English and French for Canada, UK English, French, Spanish, and German. The footer is where the detail is for customer support, legal, investors, and internal links to pages–but not Audio. One drawback this Editor sees is that once on the foreign sites, you are unable to return to the US English website as the dropdown does not link back to the US.  
  • Entering masimo.com still redirects you to the Canadian shop domain and pages that feature the pulse oximetry device and app (SafetyNet Alert) monitoring prescribed opioid usage for difficulties in breathing (respiratory depression). Clicking on support features only ‘hearables’ and opioid safety–an educated guess is that this supports a specific Canadian initiative and is maintained for that only. Clicking on the tabs above will lead you to the new masimo.ca website pages which have no mentions or links back to opioid information. 

The investigation into the cyberattack that brought all Masimo IT systems down is ongoing. What is not known is 1) the type of the attack, 2) acknowledgement of the extent of the attack, and 3) any lasting damage to their internal systems, databases, and manufacturing systems. This Editor will be waiting to see if the new Masimo will be transparent with customers, investors, and the press as to what happened, the remediation of their systems, and securing their IT. Customers will need reassurance that their continuous monitoring and patient-worn monitoring devices are secure. Moreover, Health and Human Services’ Office of Civil Rights (HHS-OCR) requires reports of data breaches affecting or potentially affecting protected health information (PHI). I will also be waiting to see if their consumer health wearables bounce back and go back on sale (they are currently unavailable)–after winning their fights with Apple, it would be a shame if this investment is abandoned. 

More on this in Strata-gee 15 May. More good news–Editor Ted Green is recuperating and back at his desk, if only part-time. He has been invaluable for his inside looks at Masimo’s endless drama over the past few years. Thank you for the hat tip to TTA at the end of this article!

Masimo’s Sound United sale–the good and the not-so. Ted digs deep into the sale of Masimo’s ill-starred Sound United unit.  As we reported previously, Samsung’s Harman International unit picked it up for $350 million in cash, a mere one-third of its 2022 purchase price of $1.025 billion–a “shockingly low valuation for such great brands” such as Marantz, Denon, Bowers & Wilkins, Polk, Boston Acoustic, and others. Clearly, a sale was the desire of the new sheriffs running Masimo, Politan Capital, and shareholders, but a 66% haircut is still shocking. The share price rose prior to the annual meeting, but is now lower, likely from the cyberattack and uncertainty around tariffs affecting Masimo’s mainline medical device manufacturing.

Harman is the home of other storied audio brands such as Harman/Kardon, JBL, AKG, Mark Levinson, Arcam, and Revel. While a small part of giant Samsung, it is not puny in revenue, ending their 2025 at $10.2 billion. Because Strata-gee and Ted focus on the audio business, there is an extensive discussion here on how the Sound United brands will fit into the Harman portfolio and whether they will expand Harman’s business which has been rather flat. For Harman, consumer audio is their growth opportunity, from premium audio to headphones, and they just bought a quality group. The downside is that some of the brands collide in their market segments, notably B&W and Revel in the audiophile segment and Denon and Marantz versus ARCAM and JBL in audio video receivers (AVR). Interestingly, their largest segment is automotive electronics: car audio, telematics, and digital cockpits. For a more complete analysis, catch Ted’s Strata-gee article, ‘Temper Your Enthusiasm’, here.

TTA’s Blooming Spring 3: Masimo’s cyberattack takes it down, WW’s Chapter 11, Neuralink’s ALS success, UHG’s 1K bet on AI apps, NIH/CMS autism data project, a look at payer earnings, more!

May 9, 2025 | by

9 May 2025

This week’s drama was all about Masimo, developing literally as this Editor was writing. Their website outage was revealed to be from a cyberattack that took down nearly all their systems. Not good for a monitoring/tech company. But their good news was that they sold Sound United to Samsung–2/3rds off. The others deserving of more attention are Neuralink’s successful BCI implant in an ALS subject and UHG’s 1,000 app bet on AI. Not so dramatic: WeightWatchers’ prepackaged, quick bankruptcy, the NIH/CMS autism data project, and Amedisys divesting to salvage their UHG sale. 

Short takes: HHS forms NIH/CMS autism data project; Oscar Health beats Street w/Q1 $275M net; Centene’s $1.3B earnings; UHG has class action suit on earnings, 1K AI apps in production; Cedars-Sinai and Redesign Health partner on development; FDA, Lilly, Novo Nordisk win vs. compounders (Big step forward for autism research)

News roundup: WeightWatchers in 45-day prepackaged Ch. 11, Neuralink BCI successful in ALS subject, telehealth VR reduced TMD pain–study, AliveCor maxes up KardiaMobile 6L, TytoCare-Allina Health partnership, UHG-Amedisys divest some more (WW losing runway, a Neuralink win, Amedisys divesting to save their two-year-old UHG deal)

Breaking–Masimo Mystery SOLVED–cyberattack, website down for days, new websites up–and where’s the public explanations? Sound United sold. (Another cleanup on Aisle 10–the Sound United albatross flys off)

From last week: Cherry blossoms are starting to fall, much like Teladoc’s revenue for Q1 in our lead story. Can their acquisition of a small virtual mental health provider with insurance coverage help turn around BetterHelp? And what about their main business? Novo Nordisk would rather partner than fight with teleprescribers Hims & Hers, Ro, and LifeMD for GLP-1 Wegovy–will this be a trend? Commure adds to its ‘house that Jack built’ tech stack with a HealthTap partnership. And Masimo’s latest episode of its ongoing soap opera is that its former CEO (and major shareholder) is claiming ownership of shares as part of his severance–but they haven’t been granted and very much in dispute. (Irony alert: they’ve increased in value since his departure!)

This just in: Teladoc acquires UpLift for $30M, bolstering struggling BetterHelp telemental health; Q1 revenue down 3% (Can this telemental health be saved with one acquisition?)

News roundup: Hims, Ro, LifeMD and Novo Nordisk partner on Wegovy prescribing (updated); Commure partners with HealthTap for virtual care after hours; WebMD Ignite adds texting to member health ed; hellocare.ai raises $47M for virtual nursing  (When you can’t beat ’em in weight loss meds, join ’em. With a side of Commure’s interesting M.O. on acquisitions.)

Masimo updates: former CEO Kiani claims 13.2% ownership, and a review of the new management’s style (updated) (The soap opera continues)

Holding this over: The weekend read: why SPACs came, went, and failed in digital health–the Halle Tecco analysis/memorial service; why OpenAI is going to be a bad, bad business (Grab the cuppa and lunch for a good read and podcast. Updated–Also Tecco’s blog post on why she quit being an angel investor.) 

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Breaking–Masimo Mystery SOLVED–cyberattack, website down for days, new websites up–and where’s the public explanations? Sound United sold.

May 7, 2025 | by

The Masimo website goes offline–coinciding with their investor meeting. When this Editor posted an article on former Masimo CEO Joseph Kiani’s “beneficial ownership” SEC filing (Schedule G/A, for amended) last Tuesday late evening (29 April), as we generally do, we included a link to the main corporate website. I noted the following day that the home page was down and displayed a ‘performing some maintenance’ message. This is not especially unusual in the evening, as our Readers know, but unusual to continue beyond that.

Checking Wednesday, the website remained down. Yet their consumer-direct sales ‘Shop’ and Investor Relations pages remained up if you linked to them directly, though the medical monitoring smartwatches listed on the shop page were ‘coming soon’. Consulting with Ted Green of Strata-gee, who follows Masimo from their now-sold audio business (see update below) and an excellent source for us, he followed up as it remained offline into Thursday. Press contacts there were unresponsive. An “inside source” provided the only answer obtainable, which was ‘we’re working on it’. Ted called their main line–and received a recorded message that “All circuits are busy, please try your call later”. Calling Customer Service as a final attempt, even they did not know what was going on with the website…and, while phones were working, their internal systems had gone down. Finally, late on Thursday, Ted received an email from a PR representative who pointed him to their changed message on their website stating that the website was down and that they were working to resolve the issue. Ted relates this far more entertainingly in his Search for Information. 

Certainly an unusual and embarrassing situation for a tech-based medical device company, especially one that, at least for investors, is backing up its claims of a new transparency to the max. (See their working Investor Relations page for their postings of their Q1 financial presentation, webcast, and press release). For those of us in the business, an extended ‘offline’ means that we automatically think ‘hack’–another victim of cyberattack or ransomware.

And that is exactly what it turned out to be. Masimo’s SEC Form 8-K filed yesterday led with the following:

On April 27, 2025, Masimo Corporation (the “Company” or “we”) identified unauthorized activity on the Company’s on-premise network. Upon detection, we activated our incident response protocols and implemented containment measures, including proactively isolating impacted systems. We promptly commenced an investigation and are actively working to assess, mitigate, and remediate the incident with the assistance of third-party cybersecurity professionals. The Company has also notified and is coordinating with law enforcement.

As a result of the incident, certain of the Company’s manufacturing facilities have been operating at less than normal levels, and the Company’s ability to process, fulfill, and ship customer orders timely has been temporarily impacted. The Company has been working diligently to bring the affected portions of its network back online, restore normal business operations and mitigate the impact of the incident.

The investigation of the incident remains ongoing, and the full scope, nature, and impact of the incident are not yet known. At this time, the Company believes that the incident appears unrelated to and is not affecting the Company’s cloud-based systems.

Comments below Ted’s Strata-gee article, from an anonymous commenter, said that the FBI had visited the Masimo Irvine headquarters, which lines up with the last sentence of the first paragraph. The filing confirms that the intrusion was detected on Sunday, 27 April–which does not mean that they started then, just that it was found.

It is also evidently broad and deep, not only affecting the website and internal systems used by customer service, but also internal systems used in manufacturing and at all Masimo locations are ‘locked down’ in the words of another commenter. It’s serious when orders can’t ship and most employees are reportedly being told to stay home for the better part of the week, according to commenting insiders.

According to the report in FierceBiotech, CEO Katie Szyman stated that the cyberattack will not dent the company’s financial guidance for the year.

What’s not here: what Masimo is doing to inform customers of the outage, how long it will be, changes in delivery dates of devices, and if performance of any devices has been affected.

Back to the ‘restored’ websites:

A questionable restoration of their website(s). As of Tuesday (6 May, 9 pm EDT), the Masimo website is back live–but it depends on how you enter the URL! There are apparently two websites: a finished corporate and professional product website with a Personal Health section under construction with placeholders, but other live web pages which are accessible, apparently mainly for Canada–or for US under construction or discarded designs. 

  • Masimo.com entered as this link (https://www.masimo.com) features a home page with Masimo SET and their professional products such as SafetyNet Alert, a ‘cloud-based telehealth platform’. It is a tidy, respectable, and up-to-date corporate website featuring the full line of Masimo’s many professional monitoring products. Links in header and footer are standard, including corporate information and links to investor relations. Where it is not complete: clicking on Personal Health in the footer links will take you to a URL with a path that indicates a US ‘Shop’ page but is titled Support–Masimo Customer Service. Links for four individual product areas, including ‘Health at Home & Opioid Safety’, lead only to customer support information and a repeated, annoying cookies permission popup. This website appears finished except for Personal Health.
  • But if you enter only Masimo.com, the URL immediately redirects to a Canadian shop domain page and path that features how their pulse oximetry device and app (SafetyNet Alert) can monitor prescribed opioid usage for difficulties in breathing (respiratory depression) which can prove, from their tragic case study example, fatal. The new Halo app can be downloaded on the Apple App Store or Google Play. Want to find out more about it? It goes to a page that no longer exists. 
  • Clicking on the Personal Health tab at the top, it links to another Canadian ‘Shop’ domain page highlighting that their noninvasive monitoring used by hospitals is now available for home use, but the only item for sale is the Denon PerL Pro earbuds with a Canadian dollar price. No mention of SafetyNet Alert. 
  • To find their personal health devices, one has to go to the links on the footer under Customer Service>>Track Order’. This takes you to the US ‘Shop’ path page. There three ‘Health at Home’ devices are featured without descriptions. Clicking on the ‘Shop All’ button takes you to a US path page featuring the MightySat home pulse oximeter, the W1 smartwatch, and the RadiusT temperature tracker. Unfortunately, clicking on the ‘Find A Retailer’ button on each individual page leads you to a 404 page–‘That Page No Longer Exists’. 
  • These pages are in layout and style unlike the corporate website. Formats vary all over the lot.
  • On other pages linked in the footer, it appears there are some new pages, along with old web pages restored without updating.
  • Extremely annoyingly, on every page or return to a page, a permission popup for accepting cookies blocks the page until you accept or decline.

Where’s the project/marketing manager supervising this? Again, it’s embarrassing for a digital health technology company, even post-cyberattack, to have this level of visible website disorganization, coupled with days offline and reports of complete disruption. The best approach would be a minimal website until a finished website, working on all URLs and paths, is completed. Other than the main corporate website, the ‘Canadian’ and other pages should be offline until discarded or finalized.

As of 13 May, there are still problems and ‘holes’ in the websites, with the tracking the same.

Update–Sound United sold. Also announced yesterday (6 May) was the $350 million cash sale of Sound United to HARMAN International, a wholly-owned subsidiary of Samsung Electronics Co., Ltd. The definitive agreement release did not mention staff transitions. HARMAN’s audio products include Harman Kardon, JBL, and AKG. The sale is scheduled to close by the end of 2025. The sale was mentioned several times during the Q1 earnings call but HARMAN was not mentioned. The sale is not included in Masimo’s 2025 forward outlook, versus the considerable impact of tariffs on their imports from China and Malaysia.

Sound United’s sale for a third of its purchase price is the finale of a very big, very bad billion-dollar bet made by Joe Kiani and his management team in 2022. The ‘vision’, such that it was, was that the audio brands would leverage consumer health wearables into retailers such as Best Buy. It didn’t. The buy immediately tanked the value of the company by an estimated $5 billion in one day, and kicked off a long trail of investor unrest that resulted in a takeover by Politan Capital and the ouster of Kiani and his board members last year. The rest, as they say, is history. (And Joe Kiani is likely enjoying a good bottle of vintage Pol Roger and shivering with schadenfreude.) Wall Street Journal