Issue 213

Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

Here are a few quick bullets on things happening in FDA-regulated and pharma-focused digital health:

• Back in 2019, Roche-owned Genentech acquired the assets of Vital Art & Science, developers of an FDA-cleared digital device called myVisionTrack. Genentech has been relatively quiet about myVisionTrack since then but this week it noted that myVisionTrack is now FDA-registered as a SaMD. The FDA’s database shows that myVisionTrack is registered as a Class 1 device — but previous versions of the device have been registered as a Class 1 device since 2013. This new iteration, however, uses BrightInsight’s platform to power it. While myVisionTrack is owned by Roche, Roche’s partner BrightInsight is listed in the FDA’s database as the manufacturer. “myVisionTrack provides a vision test that allows patients with retinal diseases to self-track changes in their vision and automatically alerts one’s physician if a patient’s sight starts to deteriorate.”
• The US International Trade Commission (ITC) once again announced a decision that it would ban imports of Apple Watches after finding that Apple had infringed on another company’s patents. This time the ITC made the ruling over Apple’s dispute with Massimo, a maker of blood pressure devices. The ITC announced a similar decision last year following Apple’s dispute with AliveCor. In the AliveCor case, the ITC said it would not enforce its import ban on Apple Watches until after the related patent lawsuits underway within the US patent office’s court systems are resolved.
• Kinsa, makers of an FDA-cleared smart thermometer, shut down last week. Over the years the company managed to distribute about 2 million smart thermometers, according to its website. The company gained some momentum during the pandemic by using its network of smart thermometers to predict COVID outbreaks based on aggregated body temperature readings. Kinsa also connected its smart thermometer users with telemedicine providers to provide urgent care remotely. So, what happened? The phrase a few former employees used in LinkedIn posts was: “Kinsa’s financing recently fell through, and we shut down core operations at the end of last week.” Kinsa CEO and Founder Inder Singh also posted on LinkedIn. He indicated that the company is still looking for a buyer: “My one last wish for Kinsa is that we succeed in finding a new home for our work — Because the science works better than I could ever have imagined.”

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One last thought on AMA’s CPT coding decisions

As I reported last week, the AMA posted the CPT coding decisions from its September 2023 meeting, including a tweak to the wording of the remote therapeutic monitoring CPT codes to make clear that “digital” cognitive behavioral therapy is included in the codes. A reader pointed out after the issue went out that the code change application also included another change that I didn’t notice at first (emphasis mine):

It’s not entirely clear why the applicants used the word “intervention”, but the original application used a different phrase:

Just speculation: Is this an attempt to create a supply code for the interventions themselves? Or is it just an attempt to not use the same phrase twice? We’ll have to wait until the Physician Fee Schedule comes out to figure out the intention here. As I speculated a few months ago, it is likely that Big Health and their partner at the APA crafted the code change application above. Big Health has previously noted that the existing RTM codes don’t provide payment for the intervention themselves — just payment for the time it takes providers to set-up and deliver them.

Trials: MedRhythms and AppliedVR

This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues. Just two this week:

Now recruiting: MedRhythms’ Curavit-powered decentralized trial OrcHESTRAS on MR-001 for chronic stroke

MedRhythms is now recruiting 225 participants for its latest study on the InTandem digital therapeutic. It also added that Curavit is powering the decentralized study. More:

Suspended: AppliedVR’s sponsor Children’s Hospital Los Angeles ended its study on AppliedVR’s digital therapeutic for pre-operative anxiety

Here’s an interesting one: This study, which supposedly started up in 2015, just terminated because its augmented reality device is no longer in business. The AR device was made by a company named Mira. It enabled users to insert their iPhones into a headmount to create a heads-up display for AR/VR apps. The Verge reported in June that Apple had acquired Mira. That report came out one day after Apple announced its own VR device, Apple Vision Pro.

Instead of finishing up in October 2022, the collaborators expect it to finish up by the end of 2026 now. More:

Prescription Digital Therapeutics Pipeline Changes

This week I revisited E&O’s Prescription Digital Therapeutic Pipelines tracker and made some significant changes. Check out the tracker here or read on for a quick list of (some of) my recent edits:

• Removed Woebot‘s digital therapeutics since the company told E&O that it was no longer exploring prescription digital therapeutics as a go-to-market.
• Removed all of Akili‘s digital therapeutics save for EndeavorRx, which remains a prescription digital therapeutic as of this writing (but likely not for long.) Akili has pivoted to a non-prescription or OTC pathway.
• Removed MedRhythms‘ Alzheimer’s PDT since it removed it from its pipeline.
• Removed Twill‘s PDT for MS which it was previously developing with Sanofi. Also, noted that Twill has said it won’t launch its Ensemble PDT if it doesn’t find a pharma partner.
• Removed Better Therapeutics‘ PDTs for Type 2 Diabetes+Hypertension as well as one for Hypertriglycerides since the company has removed those from its pipeline.
• Finally, made clear which former Pear Therapeutics’ assets went to which companies, but its unclear which of these (if any) will continue a PDT go-to-market.

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