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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Directory / Respiratory & Sleep

Respiratory & Sleep

Traferox Technologies

Mississauga, ON · Unknown · PMA approved

Builds organ preservation and ex vivo lung perfusion systems for transplant, spun out of Toronto General Hospital in 2021.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jul 15, 26	P250025PMA	TorEx Lung Perfusion System	Traferox Technologies, Inc.	Gastroenterology, Urology	PHO
Jun 1, 26	K260456510(k)	VI°Port Liver Preservation System	Traferox Technologies, Inc.	Gastroenterology, Urology	KDN

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Traferox Technologies

FDA DECISIONS ON FILE

COVERAGE