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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 / March 2026 / K254277

510(k) cleared

Embrace Neonatal MRI System

Aspect Imaging, Ltd. · Mar 13, 2026 · K254277

FDA cleared the Embrace Neonatal MRI System from Aspect Imaging, Ltd. on Mar 13, 2026 under K254277, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 30, 2025. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

Aspect Imaging, Ltd. has one other decision in the tracker over the last 12 months: K261758 (Embrace Vision Neonatal MRI System).

Questions & Answers

What did FDA clear under K254277?

K254277 is the FDA 510(k) for Embrace Neonatal MRI System, submitted by Aspect Imaging, Ltd.. FDA's decision date was Mar 13, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Embrace Neonatal MRI System?

Aspect Imaging, Ltd., based in Shoham, is the applicant of record for K254277.

How long did the K254277 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Mar 13, 2026, 73 days later.

← All decisions in March 2026

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