Issue 220
Digital health research from Brian Dolan

 E&O: Software as a Medical Device

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

• MedRhythms, developers of InTandem, an FDA-authorized, Rx-only “neurorehabilitation system for home use to improve walking and ambulation in adults with chronic stroke,” announced that two medical journals had published the results of its InTandem clinical studies. More here. 
• Biogen announced that it tapped Aptar to operate and continue to develop its digital health offerings for people with neurological and rare diseases. The deal includes Biogen’s Cleo/Aby, a digital care companion app for people with multiple sclerosis; Physio.me, a digital exercise companion for people with neuromuscular disorders. The companies will also aim to develop digital health tools for people with spinal muscular amyotrophy, Friedreich’s ataxia and lupus.
• German regulators added two more digital health apps to its national formulary for reimbursed digital health programs (DiGA). They also permanently added one that had been provisionally listed. The next few bullets have the details: 
• One of the new DiGA comes from German company MindDoc Health. It’s called “MindDoc Health on Prescription” and aims to help people with mild or moderate depression. It runs €199.
• The other new one is from Una Health and it’s called Una Health for Diabetes. It runs €740.
• Finally, Limedix’s “neolexon Aphasie” program is now permanently listed on the national formulary.

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Samsung beats Apple to OTC sleep apnea detection software with new De Novo clearance

(This was a scoop until Samsung officially announced it while I was writing it up!) 

This week the FDA granted Samsung a De Novo clearance for over-the-counter sleep apnea detection software on its Galaxy Watch and smartphone. Samsung received market authorization for the feature in South Korea already, so it was assumed to be coming to the US soon. Rumors that Apple would introduce a similar feature to its next Apple Watch also began to swirl following Samsung’s announcement last year.

The FDA’s Indications For Use for the device is reminiscent of the language it requires for smartwatch-based arrhythmia detection software:

Samsung submitted its device for FDA clearance on May 31, 2023 and received the De Novo on February 6, 2024. It took more than eight months to work its way through the FDA’s process. (Remember: Apple’s De Novo for its OTC arrhythmia detection software took just 28 days.)

Samsung’s De Novo clearance also paves the way for other companies (like Apple) to secure market authorization via the 510(k) pathways since they can use Samsung’s device as a predicate. Here’s how the FDA describes the generic type of medical device that this De Novo created:

CPT meeting updates: RTM codes withdrawn, but three other digital health requests likely made it onto the final agenda of last week’s meeting

The American Medical Association’s most recent CPT Editorial Panel meeting took place last week, but (unless you attended the secretive session) we won’t know which code applicants made it through until later this month. An update to the meeting’s agenda, however, showed that a few of the code change requests that E&O has been tracking were withdrawn just before the meeting took place. Again, it’s not yet clear whether the ones that were still on the table for the session were rejected during the meeting’s proceedings. When a code change application is withdrawn its details are removed from the agenda. So, here’s a reminder of what they focused on along with an update on where they stood just before the meeting last week:

As I reported back in December, someone had asked the AMA to “restore” the prior language for Remote Therapeutic Monitoring Services under the header of “Digital Cognitive Behavioral Therapy,” which seems like an attempt to undo the language change to the RTM codes that I wrote about back in October. This request was withdrawn before the meeting last week.

Withdrawn: Request for new RTM device supply codes and other RTM tweaks

As I wrote in December, this request looked like a major rewrite and reshuffling of the RPM and RTM code sets. It also aimed to establish two device supply codes. However, this set of requests was also withdrawn prior to the meeting.

Probably went to a vote: Request for codes for online digital evaluation of established patients 

Similar codes to the above exist today but for established patients only. This tweak could be particularly meaningful to text-based virtual care companies because it adds new patients. CMS has historically interpreted these codes to refer to messages only and not in-person or video communications. This code change request seemed to make it into the agenda at the meeting so we’ll have to see how it fared later this month.

Two digital health-related Category III code applications also seemingly made it into the meeting’s final agenda: These codes look particularly relevant for AliveCor, which has established partnerships with drug companies to use its devices for similar use cases, so I wouldn’t be surprised if they are behind them:

and

Trials: Apple-Janssen, GAIA, Woebot

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

Revised Enrollment (again): Apple’s Heartline study originally anticipated 150,000 then said 24,000 then said it had enrolled 34,244 last year — now: 45,472.  Once again Apple and Janssen revised their high-profile Heartline study’s enrollment total. Since it was done recruiting a year ago when it said it had enrolled 34,344 participants — I figured that was that. Somehow, the study now has 45,472 participants enrolled based on a recent update to the study’s listing. Still a far cry from the originally hoped-for 150,000.

Three new studies from GAIA on digital therapeutics for hypertension, MS, and more

GAIA continues to roll out studies on its growing portfolio of digital therapeutics. Here’s one on Levidex, a digital therapeutic for Multiple Sclerosis, which is now recruiting. Another on Liebria, a digital therapeutic for hypertension, which is not yet recruiting. And a third on Mylovia, a women’s health-focused digital therapeutic, that is also not yet recruiting.

Woebot updates two previous studies and posts a new one

Woebot updated its completed study on user satisfaction with its BUILD mobile app to clarify that the company does intend to submit it to the FDA. Woebot’s feasibility and acceptability study on W-PPMA, a digital health tool designed for people postpartum that delivers evidence-based therapy through brief “conversations” with a fully automated relational agent named Woebot, will finish at the beginning of March. Here’s a new study from Woebot focused on establishing proof of mechanism:

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