7.25.25
10 min. Read

CMS RFI review: 12 ideas from health tech cos

Issue 251

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 is tough to categorize as it spans a few different business models. Earlier this year, CMS put out a request for information, which included a number prompts and questions about how

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All Prescription Digital Therapeutics National Virtual Clinics Selling to Employers
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Big Health’s 2024 revenue shrinks. 2025: Runway worries.
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Kavira Health pricing. What did Swing Therapeutics buy? PFS Comments.
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Cerebral’s $25M M&A. Amazon-Fay. Oshi growth numbers.
9.12.25
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Letters to CMS: DMHT codes, MDPP pricing, more. Plus: Unannounced funding.
9.05.25
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Pricing updates: Teladoc, Maven, Garner, Kaia and more
8.29.25
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Pricing for Aetna Transform and 2nd.MD. Teladoc on PFS. Plus: Secret funding.
8.22.25
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New wearable BP 510(k) sheds light on Whoop-FDA. Trials: BetterHelp, Click, DynamiCare, Axena, Kaiser
8.08.25
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CMS proposes changes to digital mental health G codes, four year test of online DPP reimbursement.
7.16.25
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Digital mental health G code adoption “slow and challenging”
7.11.25
9 min. Read
FDA clears Lumosity-maker’s DTx for ADHD. Withings 510(k) for ECG app.
6.16.25
5 min. Read
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