7 Jul 2026 · 1 min read
UpDoc’s 510(k) cleared “concierge doctor” leaves a liability hole
UpDoc has received the first FDA clearance for a patient-facing clinical LLM via the 510(k) pathway — but I see a serious liability gap: when a cleared "concierge doctor" gets an insulin dose wrong, the accountability chain runs back through a device authorization that never contemplated the model making the call.