INNOVATE Corp. announced that its equity method investment MediBeacon received EU CE Mark certification under MDR for its TGFR Monitor and Reusable Sensor on March 31, 2026.
Key takeaways
MediBeacon, INNOVATE's equity method investment, received EU CE Mark for TGFR Monitor and TGFR Reusable Sensor under EU MDR 2017/745.
Certification covers two Class IIa devices, enabling potential use in European clinical trials.
TGFR System assesses kidney function transdermally using Lumitrace injection, approved in U.S. and China.
CE Mark supports MediBeacon's U.S. and China clinic entry and underscores quality standards commitment.
Lumitrace EU submission is pending; system includes CE marked Disposable Ring.