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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 / January 2026 / P240014

PMA approved

MAGiC Ablation Catheter

Stereotaxis, Inc. · Jan 5, 2026 · P240014

FDA approved the MAGiC Ablation Catheter from Stereotaxis, Inc. on Jan 5, 2026 under P240014, an original premarket approval. The device falls under product code LPB, Cardiac Ablation Percutaneous Catheter as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 12, 2024. The decision came 633 days later.

Stereotaxis, Inc. has 2 other decisions in the tracker over the last 12 months: K253473 (Synchrony), K251792 (Stereotaxis GenesisX RMN with Navigant Workstation (NWS)).

Questions & Answers

What did FDA approve under P240014?

P240014 is the FDA PMA for MAGiC Ablation Catheter, submitted by Stereotaxis, Inc.. FDA's decision date was Jan 5, 2026, under product code LPB (Cardiac Ablation Percutaneous Catheter).

Who makes the MAGiC Ablation Catheter?

Stereotaxis, Inc., based in Saint Louis, MO, is the applicant of record for P240014.

How long did the P240014 review take?

FDA received the submission on Apr 12, 2024 and issued its decision on Jan 5, 2026, 633 days later.

← All decisions in January 2026