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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 / July 2026 / P250025

PMA approved

TorEx Lung Perfusion System

Traferox Technologies, Inc. · Jul 15, 2026 · P250025 · In the directory

FDA approved the TorEx Lung Perfusion System from Traferox Technologies, Inc. on Jul 15, 2026 under P250025, an original premarket approval. The device falls under product code PHO, Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs as a Class 3 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 7, 2025. The decision came 373 days later.

Traferox Technologies, Inc. has one other decision in the tracker over the last 12 months: K260456 (VI°Port Liver Preservation System).

Questions & Answers

What did FDA approve under P250025?

P250025 is the FDA PMA for TorEx Lung Perfusion System, submitted by Traferox Technologies, Inc.. FDA's decision date was Jul 15, 2026, under product code PHO (Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs).

Who makes the TorEx Lung Perfusion System?

Traferox Technologies, Inc., based in Mississauga, is the applicant of record for P250025. The company is listed in the MedDevice Startups directory.

How long did the P250025 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Jul 15, 2026, 373 days later.

← All decisions in July 2026

Sources

In the startup directory

Traferox Technologies

Respiratory & Sleep · Mississauga, ON