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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 / Cardiovascular

Cardiovascular Orthopedics & Spine

MiRus

Marietta, GA · Growth · 510(k) cleared

Builds spine and orthopedic implants from molybdenum-rhenium alloys, with 24 510(k) clearances, and is developing SIEGEL, a nickel-free balloon-expandable TAVR valve in the STAR trial. Boston Scientific owns about 34% after a $1.5B investment in May 2026.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Mar 18, 26	K253444510(k)	EUROPA Posterior Cervical Fusion Navigated Instruments	MiRus, LLC	Neurology	OLO
Feb 19, 26	K252733510(k)	ATLAS Expandable Osteotomy Wedge System	MiRus, LLC	Orthopedic	PLF

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MiRus

FDA DECISIONS ON FILE

COVERAGE