#Fda

The first over-the-counter glucose monitor, cleared for people who are not sick; the least-invasive brain implant on the market and what its 510(k) does and does not allow; and the hospital where more than one company’s brain data is collected. FDA records first, with the clearance numbers checked against the database.

Woebot spent years pursuing FDA clearance for evidence-based AI therapy. Character.AI let teenagers talk to unmonitored chatbots. Woebot shut down. Character.AI grew. The contrast writes itself.