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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 / K263380

510(k) cleared

STAR Apollo Mapping System

Rhythm AI, Ltd. · Oct 23, 2026 · K263380

FDA cleared the STAR Apollo Mapping System from Rhythm AI, Ltd. on Oct 23, 2026 under K263380, a special 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 24, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Rhythm AI, Ltd. has one other decision in the tracker over the last 12 months: K253733 (STAR Apollo Mapping System).

Questions & Answers

What did FDA clear under K263380?

K263380 is the FDA 510(k) for STAR Apollo Mapping System, submitted by Rhythm AI, Ltd.. FDA's decision date was Oct 23, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the STAR Apollo Mapping System?

Rhythm AI, Ltd., based in London, is the applicant of record for K263380.

How long did the K263380 review take?

FDA received the submission on Sep 24, 2026 and issued its decision on Oct 23, 2026, 29 days later.

← All decisions in October 2026

Sources