Perimeter Medical Imaging AI (PINK.V) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) today for their Optical Coherence Tomography (OCT) imaging system, according to a press release.
The 510(k) give Perimeter the FDA nod to sell their device. It’s a requirement for any medium-risk medical device or in-vitro diagnostic product in the United States, and is formally known as a pre-market notification. The 510(k) includes detail technical, safety and performance information about a medical device.
“This is an exciting and important milestone for Perimeter that enables us to bring our ‘commercial ready’ OCT Imaging System to the U.S. market. Throughout clinical development, we listened to our users, and this clearance covers a product that delivers on their feedback, allowing for a streamlined integration into current intraoperative workflows. We are thrilled to bring physicians our platform providing ‘real-time’ margin visualization to assist their decision making, and our goal is to help them create better long-term outcomes for patients while lowering costs to the healthcare system,” said Jeremy Sobotta, Perimeter’s CEO.
Perimeter Medical Imaging AI is a Toronto-based company involved in the development and commercialization of advanced imaging tools that would expand the powers of surgeons, radiologists and pathologists to see microscopic tissue during a clinical procedure.
OCT is an imaging technique that uses low-coherence light to derive two and dimensional images from biological tissue on a really small scale. It examines tissue microstructures during surgical procedures by providing real-time margin visualization far underneath what the human eye can perceive.
“Our Perimeter OCT Imaging System is the foundational building block that allows us to continue developing ‘next-gen’ improvements, such as the artificial intelligence tools currently in development under our ATLAS AI project,” said Sobotta.
Perimeter’s shares rose $0.24 on the news and are now trading at $4.33.
Full disclosure: Perimeter Medical Imaging AI is an equity.guru marketing client.