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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 / Neurology & Neurotech

Neurology & Neurotech Cardiovascular

Perfuze

Galway, Ireland · Series A · 510(k) cleared

Makes aspiration and access catheters for mechanical thrombectomy in ischemic stroke, including the 0.088-inch Millipede88.

FDA DECISIONS ON FILE

3 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Aug 12, 26	K262399510(k)	Millipede System	Perfuze, Ltd.	Cardiovascular	NRY
Jul 9, 26	K253901510(k)	Millipede88 Access Catheter	Perfuze, Ltd.	Cardiovascular	QJP
Mar 16, 26	K253590510(k)	Millipede System	Perfuze, Ltd.	Cardiovascular	NRY

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Perfuze

FDA DECISIONS ON FILE

COVERAGE