Dune Medical Devices receives FDA clearance for MarginProbe modifications
Dune Medical Devices announced this week that the FDA has granted 510(k) clearance to modifications made to the company’s MarginProbe 1.2 breast cancer surgical device.
Dune said in a statement that these modifications make the device compliant with Restriction of Hazardous Substances requirements needed to sell into the European Union; the U.S. is expected to adopted the requirements in the near future.
“We are continuing to listen to our customers by investing in technology to enhance MarginProbe,” Dan Hashimshony, PhD, Dune Medical Devices CEO and founder, said in a prepared statement. “Once completed, these changes will enable Dune Medical Device to continue to develop products that will improve the standard of care in breast conserving surgery and allow physicians and patients to be confident that 'they got it all' in the first surgery.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.