The US regulatory approval enables the new FullFocus Viewer for the in vitro diagnostic (IVD) use with Philips' Ultra Fast Scanner
Paige, a US-based computational pathology firm, has received the US Food and Drug Administration (FDA) 510(k) approval for its digital pathology image viewer FullFocus, for primary diagnosis.
The US regulatory approval enables the new digital pathology viewer for the in vitro diagnostic (IVD) use with Philips’ Ultra Fast Scanner, and clears path for use with additional IVD Whole Slide Imaging (WSI) scanners in the future.
FullFocus has been granted the CE Mark approval in November 2019, and the company has early access trials with healthcare organizations across the US, Europe and Brazil.
Paige CEO Leo Grady said: “The COVID-19 pandemic has made it painfully clear that pathologists need better solutions to work safely and remotely. Pathology labs, hospitals and biopharma companies need to serve patients and conduct research with little disruption, without having to be physically present at their labs.
“Receiving FDA clearance for the FullFocus viewer allows Paige to further its commitment to modernizing workflows for pathologists so that they can manage their ever-increasing workloads in an efficient, organized, collaborative and secure way and ultimately help patients get the right care at the right time.”
FullFocus viewer operates on the Paige platform
According to the company, lack of interoperability, requirement of capital and on-premise storage constraints have been the challenges in adoption of digital pathology.
The FullFocus viewer was initially created and validated at Memorial Sloan Kettering Cancer Centre (MSK) to facilitate researchers and pathologists to view and navigate digital images of surgical pathology slides acquired on all major commercial brands of WSI scanners.
Based on 18 months of daily use for retrospective slide review by dozens of practicing pathologists at MSK, the company refined the digital pathology viewer.
Paige has enhanced FullFocus to meet the performance requirements for IVD use, with accurate colour reproducibility, optimised viewing speeds and adherence to a certified quality management system.
In addition, the company is working to expand the diagnostic device to incorporate with additional WSI scanners and monitor displays in the future. Designed to be rapidly deployed in any clinical setting, FullFocus viewer operates within the Paige Platform, and requires minimal upfront costs.
MSK digital pathology informatics director Matthew G Hanna said: “A viewing and storage platform that is interoperable with various existing digital pathology tools could enable pathologists to collaborate with their team, remotely, without sacrificing security and privacy, all essential pieces of ‘going digital’ in pathology.”