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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 / November 2025 / P240026

PMA approved

OncoMate® MSI Dx Analysis System

Promega Corporation · Nov 5, 2025 · P240026

FDA approved the OncoMate® MSI Dx Analysis System from Promega Corporation on Nov 5, 2025 under P240026, an original premarket approval. The device falls under product code SFL, Nucleic Acid Based Assay, Microsatellite Instability as a Class 3 device. The review panel was Medical Genetics.

FDA logged the submission as received on Jul 26, 2024. The decision came 467 days later.

Promega Corporation has one other decision in the tracker over the last 12 months: P250046 (OncoMate® MSI Dx Analysis System).

Questions & Answers

What did FDA approve under P240026?

P240026 is the FDA PMA for OncoMate® MSI Dx Analysis System, submitted by Promega Corporation. FDA's decision date was Nov 5, 2025, under product code SFL (Nucleic Acid Based Assay, Microsatellite Instability).

Who makes the OncoMate® MSI Dx Analysis System?

Promega Corporation, based in Madison, WI, is the applicant of record for P240026.

How long did the P240026 review take?

FDA received the submission on Jul 26, 2024 and issued its decision on Nov 5, 2025, 467 days later.

← All decisions in November 2025