The digital health ecosystem has swelled to encompass a broad range of products over the years.
On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time worrying about oversight from the Federal Trade Commission than the health regulator. [Read more…] about Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA
“A portable device that can quickly measure electrical activity in the brain and relay it to doctors via a smartphone app, called the Nurochek system, has been cleared by the United States Food and Drug Administration (FDA) for use as a medical device. [Read more…] about Portable brain assessment device by Headsafe secures 510(k) FDA clearance
“Akili Labs has kicked off open enrollment for a clinical trial of its Project EVO video game platform in a quest to secure for 510(k) clearance from the U.S. Food and Drug Administration for its lead indication [Read more…] about Large multi-center study to test videogame-like digital therapy as (potentially) FDA-cleared ADHD treatment