The clearance is important to Paige partly because the viewer can "serve as a delivery vehicle for other advanced technology we're building," Leibowitz said. The image viewer allows pathologists to securely view scanned images in the cloud from different geographic locations and from their homes during the emergency-use period, Leibowitz said. The FDA greenlighted FullFocus to help pathologists review, interpret, and manage digital images of tissue slides for primary diagnosis. The viewer and other products in Paige's product development pipeline have the potential to push broader acceptability of digital pathology products, Carla Leibowitz, Paige's chief business development officer, said in an interview. The US Food and Drug Administration in July cleared the firm's FullFocus viewer software for viewing and management of digital images of scanned surgical pathology slides obtained using the Philips Ultra Fast Scanner. NEW YORK ─ After receiving 510(k) clearance for its image viewing software, New York-based Paige is working toward receiving additional regulatory clearances for its artificial intelligence-based digital pathology products, and increasing the adoption of digital pathology workflows.
0 Comments
Leave a Reply. |