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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 / March 2026 / P250024

PMA approved

Trilogy Transcatheter Heart Valve System

JenaValve Technology, Inc. · Mar 17, 2026 · P250024 · In the directory

FDA approved the Trilogy Transcatheter Heart Valve System from JenaValve Technology, Inc. on Mar 17, 2026 under P250024, an original premarket approval. The device falls under product code NPT, Aortic Valve, Prosthesis, Percutaneously Delivered as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 30, 2025. The decision came 260 days later.

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

Questions & Answers

What did FDA approve under P250024?

P250024 is the FDA PMA for Trilogy Transcatheter Heart Valve System, submitted by JenaValve Technology, Inc.. FDA's decision date was Mar 17, 2026, under product code NPT (Aortic Valve, Prosthesis, Percutaneously Delivered).

Who makes the Trilogy Transcatheter Heart Valve System?

JenaValve Technology, Inc., based in Irvine, CA, is the applicant of record for P250024. The company is listed in the MedDevice Startups directory.

How long did the P250024 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Mar 17, 2026, 260 days later.

← All decisions in March 2026