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THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Directory / Cardiovascular

Cardiovascular Imaging & Radiology

LUMA Vision

Dublin, Ireland · Unknown · 510(k) cleared

Builds VERAFEYE, a catheter-based cardiac imaging and navigation platform that produces 2D, 3D and 4D views of the heart and tracks imaging and ablation catheters during electrophysiology procedures.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jul 24, 26	K261849510(k)	VERAFEYE Imaging Catheter (VF-VIC-002)	Luma Vision Limited	Cardiovascular	OBJ
Jun 15, 26	K260885510(k)	VERAFEYE Imaging and Guidance System (VF-VIS-002)	Luma Vision Limited	Unknown

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LUMA Vision

FDA DECISIONS ON FILE

COVERAGE