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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / September 2026 / K254302

510(k) cleared

ECG Analysis Software (AiTiALVSD)

Medical AI Co., Ltd. · Sep 30, 2026 · K254302

FDA cleared the ECG Analysis Software (AiTiALVSD) from Medical AI Co., Ltd. on Sep 30, 2026 under K254302, a traditional 510(k). The device falls under product code QYE, Reduced Ejection Fraction Machine Learning-Based Notification Software, regulated at 21 CFR 870.2380 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 31, 2025. The decision came 273 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medical AI Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)), K254260 (The VEGA Cervical Screw System).

Questions & Answers

What did FDA clear under K254302?

K254302 is the FDA 510(k) for ECG Analysis Software (AiTiALVSD), submitted by Medical AI Co., Ltd.. FDA's decision date was Sep 30, 2026, under product code QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software).

Who makes the ECG Analysis Software (AiTiALVSD)?

Medical AI Co., Ltd., based in Gangnam-Gu, Seoul, is the applicant of record for K254302.

How long did the K254302 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Sep 30, 2026, 273 days later.

← All decisions in September 2026