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

THE TAPE

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 Directory / Women's Health

Women's Health GI & Urology

Axora Medical

Sunnyvale, CA · Unknown · 510(k) cleared

Sells devices for office-based gynecology, including the HERizon Vista hysteroscopy platform and the Symphion tissue removal system. It distributes Porter Instrument's Nitronox Plus nitrous oxide system to US gynecology practices.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Aug 18, 26	K260984510(k)	HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)	Axora Medical, Inc.	Obstetrics/Gynecology	HIH

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