INNOVATE Corp. (NYSE: VATE) shares began Tuesday in the green. The New York-based company announced that MediBeacon Inc., a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, and an equity method investment of INNOVATE, announced receipt of European Union (EU) CE Mark certification under the EU Medical Device Regulation (MDR) for its TGFR™ Monitor and TGFR™ Reusable Sensor. The certification confirms that the Monitor and Sensor have met the robust safety, quality, and performance standards required under the EU MDR 2017/745.
“Obtaining the EU CE Mark is a significant milestone for MediBeacon,” said MediBeacon CEO Steven Hanley.
MediBeacon received certification across two Class IIa devices, the TGFR Monitor and TGFR Reusable Sensor. The two, coupled with the Lumitrace® (relmapirazin) injection and the CE marked TGFR™ Disposable Ring, comprise the TGFR System, which enables the assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body.
The result is a transdermal assessment of Glomerular Filtration Rate or kidney function (tGFR). Lumitrace (relmapirazin) injection is approved in the U.S. and China. Submission of Lumitrace (relmapirazin) injection to the EU regulatory authorities is pending.
VATE shares captured 25 cents, or 4.6%, to $5.75.
