FDA

Health & Wellness 7 min Four AI Devices Reach Medicare Patients Without Clearance, or a Review Board The FDA's TEMPO pilot sets aside more than marketing authorisation. Enforcement discretion also covers the IDE... AM Amelia Wong 3 Sep Health & Wellness 6 min The Cancer Blood Test Going to the FDA Missed Its Primary Endpoint GRAIL's test goes to an FDA advisory committee on 23 September, the first of its kind to get there. The trial... AM Amelia Wong 31 Aug Health & Wellness 6 min J&J Says the FDA Authorised Its OTTAVA Surgical Robot — Almost Nothing in the Announcement Can Be Checked Yet The release never says "nine procedures". Both performance claims cite unpublished internal documentation. And... AM Amelia Wong 26 Jul Health & Wellness 9 min The FDA Is Reviewing 7 Peptides on 23–24 July — Here's What That Does and Doesn't Mean The FDA's Pharmacy Compounding Advisory Committee will review seven peptides — BPC-157, KPV, TB-500, MOTS-c, E... AM Amelia Wong 9 Jul Health & Wellness 8 min Researchers Push Back on the FDA's 2026 Wellness-Device Guidance — What It Means for Wearable Owners A Nature Biomedical Engineering Comment published on 23 June 2026 argues that the FDA's 2026 General Wellness... AM Amelia Wong 2 Jul Health & Wellness 5 min The FDA wants clinical trials to report in real time, with AI doing the watching The US Food and Drug Administration has started two pilot trials that send their results to the agency as the... AM Amelia Wong 1 Jun