INNOVATE Corp. (NYSE:VATE) said MediBeacon, in which it holds a 44.7% equity stake, has received U.S. Food and Drug Administration approval for its next-generation MediBeacon TGFR System, introducing a reusable sensor intended to broaden access to point-of-care kidney function assessment.
The approval, granted Dec. 16, updates MediBeacon’s transdermal glomerular filtration rate technology, which measures clearance of its optical tracer Lumitrace (relmapirazin) through the skin.
The new TGFR Reusable Sensor replaces the earlier single-use version and is secured with a disposable adhesive ring.
MediBeacon said the design enhances patient comfort and lowers per-test costs, improving usability across clinical settings.
The company highlighted scientific validation supporting the platform, including an August 2025 lead cover article in the Journal of the American Society of Nephrology and more than 700 preclinical publications.
MediBeacon plans early access commercialization of the system beginning in the first quarter of 2026 at select academic medical centers in the U.S. and China.
The company views the reusable sensor as a critical step toward wider adoption of real-time kidney monitoring in hospitals, outpatient clinics, and eventually broader care environments.
INNOVATE, which has long identified MediBeacon as a core healthcare technology asset within its portfolio, said the approval advances commercial readiness and strengthens value creation potential as the TGFR System enters its launch phase.