Issue 218

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

 E&O: Rx Digital Therapeutics

• Big news (for everyone but E&O readers) this week was Eli Lilly’s official announcement of LillyDirect. E&O readers learned about LillyDirect and its virtual clinic partners weeks ago.
• Remember: LillyDirect isn’t a new concept for pharma companies. I’d argue it is the highest-profile example given the spotlight GLP-1s have right now, but this has been done many times before. E&O wrote about this model way back in 2021 when Accolade bought PlushCare for $450 million. PlushCare was a DTC virtual clinic company that did quite a few deals with pharma companies to set up virtual clinics promoted right on pharma’s branded medication’s websites. A few examples I mentioned back then were: Takeda and Lundbeck’s Trintellix for Major Depressive Disorder; Genentech’s prescription flu medication XOFLUZA; Lupin’s prescription antibiotic Solosec; Duchesnay USA’s Osphena for menopause. Some of these date back to 2019 or earlier. Pre-pandemic days — so ancient history in the world of health tech.
• Click Therapeutics and its partner Boehringer Ingelheim announced that the FDA had given their prescription digital therapeutic for schizophrenia, currently code-named CT-155, breakthrough designation status. More here.
• Apple and Massimo’s patent litigation culminated in a ban on imports of recent models of the Apple Watch last month, but a federal court put a temporary stay on the ban until later this month. Patently-O has a good write-up here. This is a separate but parallel case to the one AliveCor is pursuing against Apple.
• Better Therapeutics announced a partnership with Glooko, a company that sells a diabetes management offering to providers. Better hopes Glooko can help identify potential patients for the digital therapeutic company’s AspyreRx. “In the United States alone, Glooko’s solutions have aided over 3.4 million people with diabetes and are utilized in nearly 5,000 clinic locations. AspyreRx will be accessible on the Glooko healthcare provider (HCP) platform in the U.S. as a new treatment option. Additionally, by leveraging Glooko’s ‘precision engagement’ functionality, patients who are suitable candidates for AspyreRx will be flagged for healthcare providers.”
• Alex Therapeutics and its partner Vicore Pharma announced positive results from its recent study of its 9-week, CBT-based digital therapeutic for anxiety, Almee. According to the company: “The study met its primary endpoint, change from baseline in GAD-7 anxiety scores, with a statistically significant 2.7-point improvement compared to control.”
• German regulators added another digital health app to its national formulary for reimbursed digital health programs (DiGA) and changed a few prices. HiDoc’s Cara Care program for IBS raised its price from €574.56 to €718.20. Meanwhile, Hello Better’s Sleep program lowered its price from €599 to €249. The formulary also provisionally listed a new digital health program focused on managing hypertension: Mementor’s Actensio. The program focuses on encouraging healthy eating, increased exercise, and stress management. It costs €593.81.

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FDA: Google De Novo, Akili 510(k), Tyto 510(k), Voluntis 510(k), and final guidance on digital health tech for remote data in clinical trials

Since there were a few notable FDA market authorizations in recent weeks, this turned into a round-up. Read on for recent 510(k) clearances and one new De Novo clearance that has yet to make headlines:

FDA grants Google a De Novo clearance for an infrared body thermometer built into the Pixel 8 Pro smartphone.

Details on this one are still scarce as the agency has yet to post the summary decision document. My guess is Google will announce this at CES next week and we’ll learn more. The FDA did let slip a little about this device’s intended use and Google has hinted at its plans in recent months too.

• Excludes premies: A few weeks ago an official FDA social media account posted that the De Novo for Google’s Body Temperature Software was “intended to measure the body temperature in people of all ages, excluding premature infants.”
• Temperature sensing for various surfaces, including the human body now: Interestingly, the De Novo was assigned to Google’s subsidiary Fitbit LLC even though the software is likely to first appear in Google’s Pixel 8 Pro smartphone. On a product page for that smartphone, Google pitches the phone’s ability to measure the temperature of various surfaces including food, beverages, ceramic, glass, matte metal, shiny metal, and more. However, the site includes a (now out-of-date) disclaimer in the footer that reads: “Google Pixel 8 Pro does not currently measure body temperature. The FDA (Food & Drug Administration) is reviewing this feature. If approved, it will be updated on Pixel 8 Pro.”

Akili secures a 510(k) for EndeavorRx that expands the prescription digital therapeutic’s label to include adolescents

In mid-December, Akili received a 510(k) clearance for EndeavorRx that makes the prescription digital therapeutic available to teenagers aged 13-17. It was previously cleared for kids aged 8-12. Akili submitted a label expansion request for EndeavorRx to the FDA in May 2023.

• Rx –> OTC: The company still plans to transition EndeavorRx to OTC labeling, but it doesn’t plan to submit data to support that request to the FDA until next year. Currently, Akili sells an over-the-counter version of EndeavorRx to adults under the brand EndeavorOTC. Akili has no plans to commercialize the prescription version of EndeavorRx to teens so the FDA clearance is just a vestige of its old go-to-market.

FDA granted TytoCare another 510(k) for its Wheeze Insights software

Tyto received its first 510(k) for its Wheeze Insights software in March 2023. It filed a second 510(k) for the same software just four months later and received the new clearance in December 2023. The agency hasn’t posted the summary document yet, so it’s unclear what new functionality Tyto can add to its software. Voluntis receives a 510(k) for Insulia Bolus Companion It’s been a while since I’ve taken a look at what Voluntis has been up to — the company recently secured a new 510(k). Details: “Insulia Bolus Companion includes three components:

• A mobile application for use by people with diabetes on commercially available smartphones (iPhone or Android) and tablets, enabling patients to document BG measurements, meals, and generate dose suggestions for bolus insulin
• A web-based application for use by HCPs in professional healthcare settings through a compatible web browser on a computer, allowing patient inclusion and patient monitoring in-person and by distance
• A secure database hosted in a private cloud environment and used to securely store patient data”

Final Guidance: Digital health tech for remote data in clinical trials

Finally, at the end of December, the FDA published a final guidance document for “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” that’s worth a read if you haven’t seen it yet. Here’s a quick description from the agency on what this guidance covers: “This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient.”

Trials: Stanford’s Apple Watch for pediatric arrhythmias study and Stanford’s evaluation of Bold Health’s Zemedy for IBS

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:

Stanford study on Apple Watch’s ability to detect arrhythmias in children

Researchers at Stanford are studying the Apple Watch’s ability to detect arrhythmias in children. The study, named “Leveraging Wearable Technologies for Arrhythmia Detection in Children” or “The PAW (Pediatric Apple Watch) Study” for short hopes to attract 100 participants. For the study participants will wear an Apple Watch for six months. The study has two aims:

The ECG app on the Apple Watch is currently only cleared for people who are 22 years old and older. While Apple isn’t named as a collaborator on this study, Stanford researchers are frequent collaborators with the tech giant. They might add Apple to the study’s listing later. Is this study the start of Apple’s pursuit of an expanded lable for the device that includes younger users? The study is not yet recruiting but might officially start in February. More

Stanford study of Bold Health IBS program Zemedy set to finish in March

Stanford researchers have finished recruiting participants for its evaluation study of CBT-based digital therapeutic Zemedy for IBS. The study recruited 22 of the 44 anticipated participants. The study will compare a treatment as usual arm to the experimental group. More:

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