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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 / December 2025 / K253489

510(k) cleared

Swoop® Portable MR Imaging® System

Hyperfine, Inc. · Dec 12, 2025 · K253489

FDA cleared the Swoop® Portable MR Imaging® System from Hyperfine, Inc. on Dec 12, 2025 under K253489, a special 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 Oct 24, 2025. The decision came 49 days later, inside the 90 FDA-day goal for a 510(k).

Hyperfine, Inc. has one other decision in the tracker over the last 12 months: K262622 (Swoop® Portable MR Imaging® System).

Questions & Answers

What did FDA clear under K253489?

K253489 is the FDA 510(k) for Swoop® Portable MR Imaging® System, submitted by Hyperfine, Inc.. FDA's decision date was Dec 12, 2025, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Swoop® Portable MR Imaging® System?

Hyperfine, Inc., based in Guilforf, CT, is the applicant of record for K253489.

How long did the K253489 review take?

FDA received the submission on Oct 24, 2025 and issued its decision on Dec 12, 2025, 49 days later.

← All decisions in December 2025

Sources