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MediBeacon® Transdermal GFR Monitor and Reusable Sensor Receive CE Mark Under European Medical Device Regulation
NEW YORK, March 31, 2026 (GLOBE NEWSWIRE) -- INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that MediBeacon Inc. (“MediBeacon”), 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 c
About this update from Innovate Corp.
[{"type":"image","alt":"INNOVATE Corp.","displaySize":"","headline":null,"caption":"INNOVATE Corp.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":155,"url":"https://media.zenfs.com/en/globenewswire.com/f6839c69bcfd01d6eebbc83e70475620"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/G.PVKWjLkcNrFL3YtfMMRw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIxNw--/https://media.zenfs.com/en/globenewswire.com/f6839c69bcfd01d6eebbc83e70475620","width":300,"height":155}},"lazy":false},{"type":"text","content":"NEW YORK, March 31, 2026 (GLOBE NEWSWIRE) -- INNOVATE Corp. (NYSE: VATE) (“INNOVATE” or the “Company”) announced today that MediBeacon Inc. (“MediBeacon”), 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.","length":639,"tagName":"p"},{"type":"text","content":"“Obtaining the EU CE Mark is a significant milestone for MediBeacon,” said Steven Hanley, CEO and Co-Founder of MediBeacon. “As the TGFR™ System enters the clinic in the U.S. and China, the CE Mark allows for the potential use of the transdermal technology in clinical trials that include European sites. The achievement also underscores our commitment to meeting the highest quality and safety standards.”","length":406,"tagName":"p"},{"type":"text","content":"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.","length":623,"tagName":"p"},{"type":"text","content":"“An accurate, clinical...