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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K254072

510(k) cleared

BoneVue

Curvebeam AI / Curvebeam, LLC · Sep 11, 2026 · K254072

FDA cleared the BoneVue from Curvebeam AI / Curvebeam, LLC on Sep 11, 2026 under K254072, a traditional 510(k). The device falls under product code KGI, Densitometer, Bone, regulated at 21 CFR 892.1170 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 18, 2025. The decision came 267 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 Curvebeam AI / Curvebeam, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254072?

K254072 is the FDA 510(k) for BoneVue, submitted by Curvebeam AI / Curvebeam, LLC. FDA's decision date was Sep 11, 2026, under product code KGI (Densitometer, Bone).

Who makes the BoneVue?

Curvebeam AI / Curvebeam, LLC, based in Hatfield, PA, is the applicant of record for K254072.

How long did the K254072 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Sep 11, 2026, 267 days later.

← All decisions in September 2026