5 min. Read

FDA SaMD risk categories, OUD guidance in 2021?

Issue 074

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week I wrote about Germany's first two reimbursed prescription digital therapeutics and how pharma execs think digital products should be priced. Here's what's happening this week:

(OK, this was earlier in the month but) Fitbit quietly snagged a $900,000 contract with the Department of Veterans

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It's a good one, too.

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ACCESS Model’s shockingly low payments. DMHT Rx count.

2.13.26

7 min. Read

HLTH acquisition price. Estimating Pomelo Care pricing, revenue, and more

1.09.26

7 min. Read

CMS to pay for ADHD DTx. More PFS notes. Two FDA De Novos.

11.07.25

6 min. Read

Pricing for Sword Health, Hinge Health, Joint Academy in the UK.

10.31.25

7 min. Read

Spring, Slingshot AI, Click and others write FDA about GenAI. Big Health board departs.

10.24.25

7 min. Read

Cigna clarifies new non-coverage policy for PDTs. Bevel $10M. FDA GenAI comments.

10.17.25

5 min. Read

Revisiting E&O scoops, pricing intel, revenue finds

10.10.25

7 min. Read

Big Health’s 2024 revenue shrinks. 2025: Runway worries.

9.26.25

5 min. Read

Kavira Health pricing. What did Swing Therapeutics buy? PFS Comments.

9.18.25

7 min. Read

Cerebral’s $25M M&A. Amazon-Fay. Oshi growth numbers.

9.12.25

4 min. Read

FDA SaMD risk categories, OUD guidance in 2021?

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