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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K260374

510(k) cleared

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal

Empatica S.r.l. · Aug 14, 2026 · K260374

FDA cleared the Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal from Empatica S.r.l. on Aug 14, 2026 under K260374, a traditional 510(k). The device falls under product code GYD, Transducer, Tremor, regulated at 21 CFR 882.1950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 5, 2026. The decision came 190 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Empatica S.r.l. has one other decision in the tracker over the last 12 months: K252981 (EmbraceMini).

Questions & Answers

What did FDA clear under K260374?

K260374 is the FDA 510(k) for Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal, submitted by Empatica S.r.l.. FDA's decision date was Aug 14, 2026, under product code GYD (Transducer, Tremor).

Who makes the Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal?

Empatica S.r.l., based in Milan, is the applicant of record for K260374.

How long did the K260374 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Aug 14, 2026, 190 days later.

← All decisions in August 2026