Imaging AI software upgrade receives FDA clearance

NinePoint Medical, a Massachusetts-based medical device company, has received market clearance from the FDA for its new artificial intelligence-based platform for image feature segmentation.

The clearance is for the company’s Intelligent Real-Time Image Segmentation (IRIS) software upgrade for its NvisionVLE Imaging System.

“The clearance of the IRIS product marks the successful culmination of a multi-year development effort within our organization and with the Food and Drug Administration,” Eman Namati, PhD, president and chief executive officer of NinePoint Medical, said in a statement.

“This product is something we at NinePoint, and our customers, are very excited to bring to market. We pride ourselves in customer responsiveness and innovation, key inputs to this new product. We are eager to roll this out in a controlled-market release in the coming months prior to making the technology more broadly available.”

The imaging system helps physicians perform a volumetric laser endomicroscopy (VLE) procedure to create high-resolution, cross-sectional images, the company stated in a press release. The IRIS upgrade uses machine-learning algorithms to “segment and visualize esophageal image features in real-time to assist clinicians as they identify and target regions of interest during an endoscopic procedure.”