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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 / Surgical & Robotics

Surgical & Robotics Neurology & Neurotech

Zeta Surgical

Boston, MA · Unknown · 510(k) cleared

Sells a navigation and robotics platform that uses computer vision for image guidance in minimally invasive procedures. The Zeta Navigation System and Zeta TMS Navigation System are FDA cleared.

FDA DECISIONS ON FILE

3 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jul 9, 26	K261471510(k)	Zeta TMS Navigation System	Zeta Surgical, Inc.	Neurology	QFF
May 1, 26	K253663510(k)	Zeta Navigation System	Zeta Surgical, Inc.	Neurology	HAW
Oct 10, 25	K251927510(k)	Zeta Navigation System (ZNS131-US)	Zeta Surgical, Inc.	Neurology	SGE

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