Issue 239
Digital health research from Brian Dolan

E&O: SaMD

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

• CMS HCPCS committee finalized its pricing for MedRhythms’ InTandem, a shoe-sensor-powered, music therapy-based prescription digital therapeutic that improves walking and ambulation in adults with chronic stroke. CMS wrote: “The 2025 monthly capped rental fee schedule amount for new HCPCS Level II code E3200 will be approximately $1,155.55 for months 1 through 3, and approximately $866.66 for months 4 through 13, resulting in a total capped payment of $12,133.25 should there be 13 months of continuous use. Fee schedules are updated annually.”
• One Health Biosensing, a new venture started by the founder and former CEO of OneDrop, Jeff Dachis, and other veteran digital health executives, is raising a round via crowdfunding for its next-gen CGM. The wearable will track EKG, activity, sleep, and blood pressure via its optical and electronic sensors and glucose, lactic acid, and urea via its micro needle-based sensors. One Health acquired IP from One Drop, which shuttered its services at the end of November 2024. Some of the IP One Health now owns stems from One Drop’s acquisition of Sano Intelligence. Interestingly, One Health aims to be a low cost alternative to the CGMs currently on the market.
• One more thing… Over in Germany, the country’s national formulary for reimbursed digital health programs (DiGA) just added provisionally added two new DiGAs: a new digital MSK program from PrehApp named shoulder companion that costs €419.00 for every 90 days of use; and an MSK program from Marcus Rehwald named eCovery, which focuses on chronic lower back pain, that costs €574.00 for every 90 days of use. The formulary also removed MyDoseCoach, a basal insulin titration app made by Italy’s Meteda. MyDoseCoach was just added in June 2024. It cost €478.80 for 90 days of use.

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NightWare’s 2024 sales: $4.3 million

Another digital health company revealed some of its recent financials in a regulatory filing related to a crowdfunding campaign it launched at the end of 2024: NightWare. NightWare offers an Apple Watch-based prescription digital therapeutic that treats PTSD-related nightmares. The company secured a De Novo clearance back in 2020. As E&O has previously reported, it is listed in some catalogs for government buyers at $6,827.62 per unit. NightWare’s growth metrics and progress to date, from the regulatory filing:

• More than 1,500 prescriptions written
• More than 225 prescribers
• More than $4.3 million in sales for 2024
• More than $4.5 million in revenue for 2023 (expenses were $3.5 million)
• More than $2 million in revenue for 2022 (expenses were $2.2 million)
• $1.1 million cash-on-hand at end of 2024.
• $391,000 worth of devices already built and ready to ship at end of 2024
• $335,000 in grants available but uncollected at end of 2024
• Enrollment in its RCT should be complete in Q1 2024
• Publication of its RCT results to follow in 4 to 6 months
• Expect to kick off a VA Pathfinder Innovation Pilot in 2025
• Main competitors and potential acquirers include J&J, Boston Scientific, Medtronic

Revenue and sales included deals with the Department of Defense, private payers, grant revenue, and sales of a clinical trial product.

Details on how RelieVRx changed after AppliedVR’s recent FDA clearance in December 2024

As E&O reported last month: Virtual reality-based prescription digital therapeutic company AppliedVR, makers of RelieVRx, a VR-based PDT for chronic lower back pain, secured a new FDA 510(k) clearance after a brief, one-month process. I speculated at the time that the clearance could just be a minor change given the short review period or it might be a clearance for a new indication. Well, the minor change guess was more correct: “The indication for use (IFU) statements of the subject and the predicate devices are identical. The differences in technological characteristics are as follows:

• The RelieVRx (RVX-3001) uses a new head mounted device (Pico G3 VR HMD) whereas the predicate device uses the Pico G2 4K VR head mounted device.
• The RelieVRx (RVX-3001) contains a new user interface for the home screen.
• The RelieVRx (RVX-3001) contains updates to onboarding sequence to include reorientation and IPD (inter pupillary distance) adjustment.
• The RelieVRx (RVX-3001) changed its reorientation functionality from long press to short press.
• The RelieVRx (RVX-3001) contains visual enhancements and other minor adjustments such as: Hocus Focus environment update, onboarding timing and SFX adjustments, skip confirmation modal, analytics improvements, and session pause while in-app menu is active for quality-of-life updates.
• The RelieVRx (RVX-3001) contains bug fixes that were not present in EaseVRx.”

Read the summary document for the 510(k) here (PDF).

Trials: Oui ends suicide ideation DTx trial early; Samsung’s big HEARTBEAT trial; Click completes migraine, short schizophrenia studies

After a bit of a hiatus, here’s a round-up of clinical trial updates from FDA-regulated digital health companies and other pharma-related digital health.

Terminated: Oui Therapeutics terminated its ambitious randomized, double blind controlled study to evaluate the safety and effectiveness of a digital therapeutic for adults with suicidal ideation and/or suicide attempts. The study aimed to recruit close to 400 participants and was conducted in collaboration with National Institute of Mental Health (NIMH). The trial ended last June but a recent update to the trial’s posting this month indicated it had been terminated. The reason given was a bit unclear to me, so I asked Oui’s founder and CEO Seth Feuerstein for a comment (more on that below). Officially, the trial posting says:

Feuerstein was not able to share details since the results of the trial haven’t been published yet, but he noted that trials end early for a number of reasons. He indicated that results from the trial were promising despite the early termination, and the company still expects to use them in a future submission to the FDA. So, we will have to wait and see.

Completed: Click Therapeutics and Boehringer Ingelheim’s exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with a digital therapeutic (CT-156) for people with Schizophrenia. E&O first wrote about this trial in July so it wrapped up pretty quickly.

This trial had a focus on user experience since one arm include five in-person visits and a handful of interviews about the DTx’s UX.

Completed: Click Therapeutics’ study on a DTx for preventative treatment of episodic migraine in late adolescents and adults who are taking Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy. This is a contender for Click’s first product that could make use of the FDA’s PDURS pathway, if that opens up for software like Click’s in the coming year or two. More on the study:

New: The size of Samsung’s new 10,000 participant smartwatch for heart health study, which is powered by Huma’s platform and conducted in partnership with researchers at Tulane, reminds me of Apple’s heart health-related studies (even though Samsung aims to enroll about a third as many as Apple did for HEARTLINE):

The digital health-related draft and final guidances FDA has planned for 2025

This is far from breaking news but as it’s still close to the start of the year, I figured I’d round up some of the digital health-related guidance documents the FDA intends to put together in 2025.

Where’s PDURS? The cherry-picked list of guidance priorities I posted below comes from FDA’s medical device office’s list. The group within the agency focused on drug evaluation (CDER) tends to post its list of forthcoming guidances mid-year. CDER is also the part of the FDA that seems to be taking the lead on the much anticipated final guidance for Prescription Drug Use-Related Software (PDURS). The draft guidance for that was published September 2023. It received a little more than a dozen comments and has since gone quiet. It didn’t make CDER’s list of guidance priorities in mid-2024, but apparently it’s never been on CDER’s past lists of guidance priorities. I’ve heard that supporters of PDURS still fully expect a final guidance and they’ve heard that the agency is still actively working on it.

Medical device-related guidances: CDRH broke up its list of priorities into an A-list, a B-list, and an “Under Construction” list. The third bucket is for guidances CDRH hopes to get to if resources permit. (Why not go with “C-list”?) That posteriority group of priorities includes two surprising ones — a revision of the Mobile Medical Apps guidance from way back and a new guidance on clinical evidence to support Digital Mental Health Treatment Devices (a term made official in the most recent CMS Physician Fee Schedule). Those are the last two in my cherry-picked list of digital health-related guidances from CDRH below: A-list final guidances include:

• Revised Final Guidance — Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision)
• Revised Final Guidance — Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)

A-list draft guidances include:

• Draft guidance — Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Pre-market Submission Recommendations
• Revised Draft guidance — Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations (revision)

B-list draft guidances include:

• Revised Draft guidance — Policy for Regulatory Status of Device Software Functions (revision of Policy for Device Software Functions and Mobile Medical Applications)

Under construction-list draft guidances include:

• Draft guidance — Clinical Evidence Considerations for Digital Mental Health Treatment Devices, including Computerized Behavioral Therapy Devices

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