regulatory
confidence high
sentiment positive
materiality 0.55
INNOVATE's MediBeacon receives CE Mark for TGFR Monitor and Reusable Sensor under EU MDR
INNOVATE Corp.
- MediBeacon (equity method investment of INNOVATE) obtained EU CE Mark under MDR for TGFR Monitor and Reusable Sensor.
- Devices are Class IIa; TGFR System enables transdermal assessment of kidney function (tGFR).
- CE Mark allows potential use in European clinical trials; Lumitrace injection approved in U.S. and China.
- Dr. Lui Forni plans to include transdermal GFR in his clinical research in Europe later this year.