Canadian surgical imaging technology developer Perimeter Medical Imaging AI announced it has received the U.S. Food and Drug Administration (FDA) breakthrough device designation for its optical coherence tomography (OCT) technology coupled with its ImgAssist artificial intelligence (AI) software.
The product is designed for the intraoperative evaluation of margins during breast cancer lumpectomy.
The company cited a new Medicare policy program (Medicare Coverage of Innovative Technology, or MCIT) that will allow it to provide national Medicare coverage for up to four years for FDA-designated breakthrough devices upon marketing authorization.
