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Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 Directory / Cardiovascular

Cardiovascular Diagnostics & IVD Digital Health & SaMD

ZBeats

Stony Brook, NY · Unknown · 510(k) cleared

Device-agnostic ECG analysis software that turns Holter and wearable patch recordings into beat and rhythm reports, including atrial fibrillation detection.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 11, 26	K261580510(k)	ZBPro Diagnostic (Version 2.0)	Zbeats, Inc.	Cardiovascular	MLO

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ZBeats

FDA DECISIONS ON FILE

COVERAGE