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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 / October 2026 / K260005

510(k) cleared

MyoVista wavECG (DG-200-B15-003)

HeartSciences, Inc. · Oct 5, 2026 · K260005 · In the directory

FDA cleared the MyoVista wavECG (DG-200-B15-003) from HeartSciences, Inc. on Oct 5, 2026 under K260005, a traditional 510(k). The device falls under product code DPS, Electrocardiograph, regulated at 21 CFR 870.2340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 2, 2026. The decision came 276 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 HeartSciences, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260005?

K260005 is the FDA 510(k) for MyoVista wavECG (DG-200-B15-003), submitted by HeartSciences, Inc.. FDA's decision date was Oct 5, 2026, under product code DPS (Electrocardiograph).

Who makes the MyoVista wavECG (DG-200-B15-003)?

HeartSciences, Inc., based in Southlake, TX, is the applicant of record for K260005. The company is listed in the MedDevice Startups directory.

How long did the K260005 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Oct 5, 2026, 276 days later.

← All decisions in October 2026

Sources

In the startup directory

HeartSciences

Cardiovascular · Southlake, TX