Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

July 21, 2020 Auto Bot Clearance, Digital Pathology, FDA, Latest, MedTech, Paige, receives, regulatory 0

Shots

  • The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future
  • In Nov’2019, FullFocus received the CE Mark, making it available to use in the EU. Paige has early access trials across the US, EU, and Brazil with healthcare organizations to serve patients and maintains a business continuity
  • FullFocus operates within the Paige Platform and allows users, meaning researchers and pathologists to view any digital image, regardless of the scanning platform used to generate the image

Click here to read full press release/ article | Ref: Businesswire | Image: Paige