WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K260656

510(k) cleared

Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M

GE Healthcare Finland Oy · Sep 1, 2026 · K260656

FDA cleared the Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M from GE Healthcare Finland Oy on Sep 1, 2026 under K260656, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 27, 2026. The decision came 186 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Healthcare Finland Oy has one other decision in the tracker over the last 12 months: K260343 (Carescape Canvas 1000; Carescape Canvas Smart Display).

Questions & Answers

What did FDA clear under K260656?

K260656 is the FDA 510(k) for Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M, submitted by GE Healthcare Finland Oy. FDA's decision date was Sep 1, 2026, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M?

GE Healthcare Finland Oy, based in Helsinki, is the applicant of record for K260656.

How long did the K260656 review take?

FDA received the submission on Feb 27, 2026 and issued its decision on Sep 1, 2026, 186 days later.

← All decisions in September 2026

Sources