6.16.25
5 min. Read

FDA clears Lumosity-maker’s DTx for ADHD. Withings 510(k) for ECG app.

Issue 248

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

 

Here's one quick note before we dig into a company looking to bring a new ADHD digital therapeutic to market as well as the latest updates on digital health-related clinical trials... but first...

  • The FDA

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It's a good one, too.
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