MediBeacon Inc. announced it received a breakthrough device designation from the FDA for the company’s transdermal GFR measurement system, which is designed to provide continuous real-time measurement of GFR with no need for blood sampling or urine collection.
Designated to be a combination product by the FDA, the transdermal GFR measurement system includes an optical skin sensor, monitor and a proprietary fluorescent tracer agent that glows in the presence of light, according to a company press release.
“We are delighted that the FDA has recognized the transdermal GFR measurement system meets the requirements for this designation,” Steve Hanley, CEO of MediBeacon, said in the release. “We look forward to continued close collaboration with the FDA as we begin our pivotal multicenter clinical study in the United States and Europe.”
The release noted that tracer agents and devices from MediBeacon, including the transdermal GFR measurement system, are not approved or cleared for human use by any regulatory agency.