Issue 252
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.
E&O: Software as a Medical Device
This week’s newsletter includes an interesting round-up of recent changes to digital health-focused clinical trials as well as a few more pertinent details surrounding Whoop’s regulatory spat with the FDA over its blood pressure insights feature. But first a few quick notes:
- Thanks to everyone who responded to last week’s reader survey. The main question was which companies should E&O write long-form reports on and E&O readers did not disappoint. Lots of names came in that were not on my radar as well as a few that were already in the hopper. If you haven’t had a chance to send in your own requests you can use the anonymous survey here or just hit reply to this newsletter.
- As promised, I’ve been monitoring comments on the proposed Physician Fee Schedule and, while there aren’t too many yet, the American Psychological Association has managed a letter writing campaign that has begun to flood the comment box with nearly identical letters (one example) from individual practitioners. The most surprising section in the letters is that the APA asks CMS to set national pricing both for the digital mental health treatment supply code as well as a similar code for supply of CBT in the RTM suite of codes: “Finally, I encourage CMS to reconsider its approach to providing clear guidance on reimbursement for the supply codes for Digital Mental Health Treatment (DMHT) (G0552) and Remote Therapeutic Monitoring (RTM) (98978). In the proposed rule, CMS continues to rely on the judgment of individual Medicare Administrative Contractors (MACs) to set reimbursement rates for these devices. However, that has resulted in a vast inconsistency in payment policy, uncertainty regarding adequate reimbursement, and a barrier to adoption of this technology. I strongly recommend that CMS adopt the RUC recommendation for 98978 and adopt a national rate for G0552.” Previously, it seemed like APA was only pushing for the G0552 code.
- Finally, With the next AMA Editorial Panel meeting coming up next month I revisited the agenda for the September meeting — where new CPT billing codes will be debated and rejected or accepted. I already noted an application to add two codes to the remote therapeutic monitoring suite that focus on remote monitoring of cancer therapy. There is also an application for codes focused on “Mobile Cardiovascular Telemetry – 93XX6 Establish external mobile cardiovascular telemetry with electrocardiographic recording and ECG data storage as a single service,” which seems to apply to devices like AliveCor’s Kardia and maybe other devices like the Apple Watch. Another application focused on the general category of biofeedback devices, which I know includes a handful of digital therapeutics: “Biofeedback Training 90X03 90901 Revise 90901, establish 90X03, and establish new guidelines/parenthetical notes to better specify reporting for biofeedback services.”
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What Aktiia’s FDA clearance for an OTC wearable blood pressure device suggests about Whoop’s regulatory stand-off with the agency
When news broke that the FDA had issued Whoop a warning letter over its failure to seek market authorization for its Blood Pressure Insights software feature, I noted that the FDA had just cleared a similar device from European startup Aktiia. At the time, however, details were scarce as the Aktiia clearance summary documents were not yet available, but this week the agency posted them to its database.
So, what does an FDA-cleared OTC wearable-based blood pressure device look like in 2025?
Well, it’s a pretty involved set-up.
The Aktiia G0 Blood Pressure Monitoring System includes not only an app and a wristworn wearable (they refer to as a bracelet) but also a traditional upper arm blood pressure cuff for calibration. The FDA is requiring the company to use the traditional cuff to calibrate the wristworn device once a day.
Yes, the wearable device that uses PPG to sense blood pressure at the user’s wrist requires a cuff to calibrate its sensing abilities every 24 hours!
That’s what it took for a PPG-based wristworn wearable to score the first OTC clearance for blood pressure from the FDA. Clunky user experience… but they have the FDA’s blessing and can build on this by iterating in future clearances.
So, you can imagine how that might have been a non-starter for Whoop when it discussed its own wrist-based blood pressure sensing plans with the FDA.
Interestingly, Donna-Bea Tillman, the former FDA official turned regulatory consultant who helped shepherd Apple through its first de novo and 510(k) clearances back in 2018, wrote about the Aktiia clearance on LinkedIn this week. She ended her comments with:
“This is an important step in the PPG-based blood pressure space. I am sure that many of you (and me too!) will be carefully watching to see who is next”
Given Apple’s penchant for secrecy, it is fair to assume that line wasn’t intended to be a hint about her former client, but the clearance seems to mark the beginning of this new device category. (Whoop seems to be learning that the hard way.)
Here’s the full device description from the recent Aktiia 510(k):
“The Aktiia GO Blood Pressure Monitoring System measures blood pressure and pulse rate (spot check) based on the analysis of Photoplethysmography (PPG) signals. Aktiia GO Blood Pressure Monitoring System consists of the following components:
- Bracelet
- Charger (for the Bracelet)
- Aktiia lnit I1 (cuff)
- Mobile App
- Backend Software and Algorithm (in the Cloud)
The Aktiia GO Blood Pressure Monitoring System hardware component, referred to as the bracelet, is responsible for PPG data acquisition on the user’s wrist. It is composed of a data logging unit called the pod and of a detachable strap that is intended to secure the pod to the user’s wrist. The pod houses the bracelet’s electronics and PPG sensor. The bracelet’s internal battery is located inside the pod and is recharged using a pin to USB docking station using a provided charger. A calibration process (also referred to as initialization) is required prior to converting blood pressure values from optical data. This calibration process uses reference blood pressure values measured with an oscillometric blood pressure monitor (cuff) also referred to as Aktiia lnit I1. The Aktiia GO Blood Pressure Monitoring System includes a mobile application for displaying data to the user and uses a cloud server referred to as the backend for data storage. The backend also hosts the algorithm which converts optical data generated by the bracelet into blood pressure and pulse rate data.”
And as a refresher, the FDA summed up its recent interactions with Whoop in its Warning Letter like so:
“At the conclusion of your firm’s calls with FDA, your firm indicated its intention to continue marketing BPI without appropriate FDA authorization despite FDA’s repeated assertions that BPI is a medical device and therefore requires FDA authorization to be legally marketed.”
And for those who missed it — on Linkedin, Whoop’s Founder and CEO Will Ahmed wrote a long post about the incident that insisted the company’s blood pressure offering is a wellness product. Here’s a highlight:
“To be clear, Whoop supports the FDA’s right to regulate medical devices. We spent years getting FDA clearance for our ECG feature that detects AFib. That’s a medical device. We follow the rules. Blood Pressure Insights, however, isn’t a medical device. And we won’t let regulatory overreach dictate how people access their own health data… This isn’t just about Whoop. It’s about your right to understand your body and your health. It’s about giving Americans access to health and wellness data. We’ll fight this. Because the data can be measured accurately, and it belongs to you.”
I’ll keep tracking this story.
Trials: Teladoc-BetterHelp, Click-Boehringer Ingelheim, DynamiCare, Cogito, Axena Health, Kaiser-reSET-O, and more
Lots of interesting clinical trial updates from recent weeks. Here are a few digital health-related trials that caught my eye:
Boehringer Ingelheim and Click Therapeutics announced that their pivotal trial for CT-155 focused on schizophrenia symptoms met its primary endpoint
This is the biggest news in digital health-related clinical trials this week:
“Boehringer Ingelheim and Click Therapeutics today announced that the pivotal Phase III CONVOKE study (NCT05838625) of CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT), met its primary endpoint. The randomized, double-blind, controlled study investigated the effectiveness and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia experiencing negative symptoms.1 The study’s primary endpoint was change in experiential negative symptoms from baseline to week 16 as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).”
New and not yet recruiting: Teladoc launches RCT focused on BetterHelp patients receiving treatment for anxiety and depression
It is pretty rare these days for a digital health company to set up an RCT if they’re not going the prescription digital therapeutic route. So, this Teladoc/BetterHelp trial, which the company expects will enroll 86 participants, is worth paying attention to:
“A digital mental health intervention (BetterHelp, Mountain View, CA) provides users with access to online therapy care for treatment of depression and anxiety. This feasibility randomized controlled trial compares clinical outcomes of an intervention group, who will enroll in the digital mental health platform, to a control group.”
New and recruiting: DynamiCare Health study focused on stimulant use disorder treatment via smartphone
This study points to a new digital therapeutic candidate underway at DynamiCare Health. The company expects to enroll about 270 participants in this study:
“This study is testing two approaches to treating Stimulant Use Disorder, or problems with cocaine, crack, methamphetamine, etc. Stimulant Use Disorder is a national epidemic in the U.S. but there is no FDA-approved medication to treat it. There is a behavioral approach that has been found to be the most effective treatment for Stimulant Use Disorder, but this study is testing whether this can be delivered by a smartphone service, remotely, such as at home.”
New and recruiting: Square2 Systems trialing platform to help providers create their own digital therapeutics
Here’s an unusual study from a company I’m not familiar with:
“This is a research study to evaluate the usability of the Cogito digital therapeutics development platform. The Cogito platform is designed to allow researchers who are seeking to embed an evidence-based behavioral therapy into a digital delivery platform to do so via a drag and drop interface with no programming skills necessary. It will provide the components for building a digital therapeutic for any health condition and population. And in this initial study, we plan to examine the usability of Cogito in building a digital therapeutic for substance use disorders (SUDs).”
More results from Kaiser’s study of Pear Therapeutics’ reSET-O
While Pear is no more its prescription digital therapeutic reSET-O lives on as a part of virtual clinic company PursueCare. This old study took place at Kaiser Permanente back when Pear was still in business. Some of the new results data suggests that only 14 patients received a prescription for reSET-O out of the 1,552 who were eligible to receive one. Of those 14 patients only five activated the app and used at least one treatment module within six months of receiving the prescription. More here.
Now recruiting: University of South Florida study on Leva postpartum pelvic floor digital therapeutic More:
“The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device. In addition to assessing feasibility, investigators also will evaluate bladder and bowel function, pelvic organ prolapse symptoms, and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum. Investigators also will assess sexual function at 3 and 6 months postpartum. Participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum.”
Study focused on developing Aria, a wearable for patients with Parkinson’s Disease More:
“The project goal is the development and early stage validation of a wearable sensor for dysphagia in patients with PD. The first phase of the program involves engineering goals relating to increasing the battery life of this sensor to 48 hours between charges and reducing the overall form factor size. The second phase of the program is to conduct focus groups with PD patients to assess sensor usability, set up burden, and design feedback. The third phase of the study will assess the feasibility of the sensor to detect and cue swallowing in a small cohort of PD patients.”
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