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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 / K253529

510(k) cleared

Peerbridge COR MDx (Cor MDx)

Peerbridge Health, Inc. · Sep 4, 2026 · K253529

FDA cleared the Peerbridge COR MDx (Cor MDx) from Peerbridge Health, Inc. on Sep 4, 2026 under K253529, a abbreviated 510(k). The device falls under product code MWJ, Electrocardiograph, Ambulatory (Without Analysis), regulated at 21 CFR 870.2800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 13, 2025. The decision came 295 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Peerbridge Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253529?

K253529 is the FDA 510(k) for Peerbridge COR MDx (Cor MDx), submitted by Peerbridge Health, Inc.. FDA's decision date was Sep 4, 2026, under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)).

Who makes the Peerbridge COR MDx (Cor MDx)?

Peerbridge Health, Inc., based in New York, NY, is the applicant of record for K253529.

How long did the K253529 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Sep 4, 2026, 295 days later.

← All decisions in September 2026