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 and deal roundup: Babylon’s $200M raise, Best Buy buys Current Health, Virgin Pulse-Welltok, Devoted Health’s $1bn raise, Withings watch gains FDA ECG clearance

October 13, 2021 | by

Babylon Health adds $200 million to the accounts–in advance of its SPAC. Babylon’s raise of $200 million (€173M) in a ‘sustainability-linked investment’ came from the strategic capital investment firm, Albacore Capital Group. With the SPAC and PIPE, Babylon will now have access to over $800 million in capital [TTA 7 Oct]. Whew! Mobilhealthnews, Babylon release 

A score for Edinburgh. Current Health, a biosensor-based monitoring and home care management/remote patient monitoring system based in Edinburgh and Boston, sold itself to US retailer Best Buy. The company recently raised $43 million in an April Series B, which makes its quick sale somewhat unusual. Terms were not disclosed other than it was a cash deal and that Current’s CEO Christopher McCann will be remaining with the company. Best Buy extends its reach into digital home health, following on their 2019 buys of GreatCall, Critical Signal Technologies for RPM, and partnership with Tyto Care.

Current had achieved FDA Class II clearance in early 2019 [TTA 7 Feb 2019], had piloted with Mount Sinai Brooklyn and in the UK, Dartford and Gravesham NHS Trust for a post-discharge monitoring program, and recently had created a “Community” initiative to build diverse longitudinal datasets for decentralized clinical trials [TTA 18 Feb]. Current Health announcement, Best Buy release, Mobihealthnews, Healthcare Dive

The wellness app-employee/health plan engagement program area continues to consolidate with Virgin Pulse’s acquisition of Welltok. In recent years, Welltok has concentrated more on data analytics and predictive capabilities in its member experience and patient acquisition/retention platforms for health plans and systems, after a start in employee wellness programs. Virgin Pulse, which exited the Richard Branson universe (despite the logo) when sold to Morgan Equity Partners in 2018, is now backed by Marlin Equity Partners. Terms and leadership were not disclosed. Virgin Pulse release, HISTalk

‘Insurtech’ Devoted Health raised a hefty $1.15 billion Series D led by Uprising and Softbank Vision Fund 2, along with a long list of returning and new investors. Icing on the cake is that they are closing in on an additional $80 million in funding to accommodate an investor. Devoted is led by former athenahealth and government IT leaders Ed and Todd Park. It’s one of the smaller in footprint tech-based Medicare Advantage providers but combines their plans with health coverage via Devoted Medical, a telehealth and in-home care provider, and partner providers. FierceHealthcare

The ECG monitoring space is now a little more crowded. Withings finally received FDA clearance for their ScanWatch’s ECG and SpO2 monitoring, nearly two years after its introduction in January 2020. It received clearance in Europe a year ago. The cleared features are atrial fibrillation detection alerts, which advises users to take a 30-second ECG readings, and SpO2 blood oxygen monitoring for detection of respiratory issues. Withings joins the Apple Watch, Fitbit, Samsung, and the grandaddy of them all, AliveCor’s KardiaMobile, for ECG monitoring–but packs this monitoring into a good-looking watch. Mobihealthnews

Fitbit unveils Ionic smartwatch earlier than expected. Their ‘Hail Mary’ pass?

August 28, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/08/Ionic-photo.jpg” thumb_width=”150″ /]Surprisingly, Fitbit has formally unveiled today (28 August) its first smartwatch, the Fitbit Ionic, on its 10th anniversary of its first tracker. It’s a slow news week in the US, being the week before the Labor Day holiday 4 Sept and in the UK this Monday with the summer bank holiday. The announcement also feels a bit like a soft reveal in a slow period. However, the industry expected an announcement later this year, so this is considered to be positive.

There’s plenty of functionality, though the watch itself from the photos (this is Engadget’s, as the press release did not supply close up pictures) is rather brick-like on the wrist. Balancing that out is a knockout of a 1.42-inch, 348 x 250 px display, the best and brightest yet in the reviewer’s estimation. It also curves a bit through nano-molding technology (NMT) to fit more comfortably on the wrist than the previous Alta tracker.

Engadget‘s test drive of an early version of the Ionic is thorough. It confirms that Fitbit went with its own proprietary OS, contactless payment and a subscription-based custom workout guide called Fitbit Coach, a rebranded Fitstar. More functions related to healthcare are:

  • Updated heart rate monitor
  • A new SpO2 blood oxygen sensor. There’s a bit of tease in the release which gives its potential in health use: “…a relative SpO2 sensor for estimating blood oxygen levels opens the potential for tracking important new indicators about your health, such as sleep apnea”
  • Sleep tracking through monitoring pulse and movement for stages of sleep (deep, REM, light, etc.). The Engadget reviewer noted the uncertain quality of tracking.
  • Integrated connection to the new edition of the Aria weight scale (release), also due in the fall

Pricing has been set at $300/£300 with the usual extra accouterments of dress and sport bands. If you can’t wait, pre-sale starts today on Fitbit.com with retail on-sale globally starting October 2017, without a specific date. For developers, the Fitbit app software development kit (SDK) will be open to developers in September 2017. 

Will this ‘Hail Mary Pass‘ save Fitbit? Like most smartwatches, it feels like a solution in search of a problem. It depends on how many true believers will upgrade from the Alta to the Ionic, or buy this rather than an Apple Watch, where first-half sales are up 50 percent versus last year to an estimated 2-3 million new units, partly on Fitbit’s faltering back. The big roll of the dice is going with a proprietary OS. Health and other apps are dependent on developers, who are going to have to make a business decision on the watch’s sales and acceptance to commit to a one-off app. 4th Quarter sales will tell….Our earlier coverage of Fitbit and related smartwatches is here.