WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / September 2026 / P250051

PMA approved

Juveena Hydrogel System

Rejoni, Inc. · Sep 28, 2026 · P250051

FDA approved the Juveena Hydrogel System from Rejoni, Inc. on Sep 28, 2026 under P250051, an original premarket approval. The device falls under product code MCN, Barrier, Absorbable, Adhesion as a Class 3 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 10, 2025. The decision came 292 days later.

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

Questions & Answers

What did FDA approve under P250051?

P250051 is the FDA PMA for Juveena Hydrogel System, submitted by Rejoni, Inc.. FDA's decision date was Sep 28, 2026, under product code MCN (Barrier, Absorbable, Adhesion).

Who makes the Juveena Hydrogel System?

Rejoni, Inc., based in Bedford, MA, is the applicant of record for P250051.

How long did the P250051 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Sep 28, 2026, 292 days later.

← All decisions in September 2026