The US FDA granted Breakthrough Device Designation to Toronto-based Perimeter Medical Imaging AI, Inc. (OTC:PYNKF) for its Optical Coherence Tomography (OCT) Imaging System coupled with ImgAssist AI. The firm aims to transform cancer surgery with imaging tools that allow visualization of microscopic tissue structures during clinical procedures.
The goal of the U.S. Food and Drug Administration’s Breakthrough Devices Program is to provide timely access to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment, and review.
Speaking about the potential uses, Perimeter’s co-founder and President of Canadian Operations Liz Munro said, "We are thrilled that FDA has granted Breakthrough Device Designation for our OCT Imaging System with ImgAssist AI, recognizing the potential of our device to offer significant advantages over existing alternatives for intra-operative evaluation of margins during breast cancer lumpectomy."
Perimeter is advancing its proprietary, next-gen artificial intelligence technology and machine learning tools through clinical development under its ATLAS AI project. After briefly dipping, shares of PYNKF rose on today’s announcement with the stock up currently over 3% to $3.43 in early-afternoon trading. Shares are up sharply in the last 12 months.
