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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 2 other decisions in the tracker over the last 12 months: K261913 (X°Port Heart Preservation System), 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