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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K262622

510(k) cleared

Swoop® Portable MR Imaging® System

Hyperfine, Inc. · Aug 19, 2026 · K262622

FDA cleared the Swoop® Portable MR Imaging® System from Hyperfine, Inc. on Aug 19, 2026 under K262622, 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 Jul 28, 2026. The decision came 22 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: K253489 (Swoop® Portable MR Imaging® System).

Questions & Answers

What did FDA clear under K262622?

K262622 is the FDA 510(k) for Swoop® Portable MR Imaging® System, submitted by Hyperfine, Inc.. FDA's decision date was Aug 19, 2026, 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 K262622.

How long did the K262622 review take?

FDA received the submission on Jul 28, 2026 and issued its decision on Aug 19, 2026, 22 days later.

← All decisions in August 2026

Sources