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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262062

510(k) cleared

CINA-Aneurysm

Avicenna.Ai · Oct 20, 2026 · K262062

FDA cleared the CINA-Aneurysm from Avicenna.Ai on Oct 20, 2026 under K262062, a traditional 510(k). The device falls under product code QBS, Radiological Computer Assisted Detection/Diagnosis Software For Fracture, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 18, 2026. The decision came 124 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Avicenna.Ai has one other decision in the tracker over the last 12 months: K262147 (CINA-Aneurysm+).

Questions & Answers

What did FDA clear under K262062?

K262062 is the FDA 510(k) for CINA-Aneurysm, submitted by Avicenna.Ai. FDA's decision date was Oct 20, 2026, under product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).

Who makes the CINA-Aneurysm?

Avicenna.Ai, based in La Ciotat, is the applicant of record for K262062.

How long did the K262062 review take?

FDA received the submission on Jun 18, 2026 and issued its decision on Oct 20, 2026, 124 days later.

← All decisions in October 2026

Sources