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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 Tracker / April 2026 / K252945

510(k) cleared

Novasight Hybrid System

Conavi Medical, Inc. · Apr 17, 2026 · K252945

FDA cleared the Novasight Hybrid System from Conavi Medical, Inc. on Apr 17, 2026 under K252945, a traditional 510(k). The device falls under product code OBJ, Catheter, Ultrasound, Intravascular, regulated at 21 CFR 870.1200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 15, 2025. The decision came 214 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Conavi Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252945?

K252945 is the FDA 510(k) for Novasight Hybrid System, submitted by Conavi Medical, Inc.. FDA's decision date was Apr 17, 2026, under product code OBJ (Catheter, Ultrasound, Intravascular).

Who makes the Novasight Hybrid System?

Conavi Medical, Inc., based in Toronto, is the applicant of record for K252945.

How long did the K252945 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Apr 17, 2026, 214 days later.

← All decisions in April 2026