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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 / February 2026 / P250034

PMA approved

Optune Pax

Novocure, GmbH · Feb 11, 2026 · P250034

FDA approved the Optune Pax from Novocure, GmbH on Feb 11, 2026 under P250034, an original premarket approval. The device falls under product code SHC, Low Electric Field Generator For Pancreatic Cancer Treatment as a Class 3 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 15, 2025. The decision came 180 days later.

This is the only decision on file for Novocure, GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250034?

P250034 is the FDA PMA for Optune Pax, submitted by Novocure, GmbH. FDA's decision date was Feb 11, 2026, under product code SHC (Low Electric Field Generator For Pancreatic Cancer Treatment).

Who makes the Optune Pax?

Novocure, GmbH, based in Baar, is the applicant of record for P250034.

How long did the P250034 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Feb 11, 2026, 180 days later.

← All decisions in February 2026