Proscia received a new FDA 510(k) clearance for its Concentriq AP-Dx digital pathology platform. The clearance introduces a Predetermined Change Control Plan (PCCP), adds cloud deployment capabilities, and expands interoperability to include the Leica Aperio GT 450 DX slide scanner.
Our readThe inclusion of a PCCP allows laboratories to adopt future FDA-cleared scanners and displays without waiting for Proscia to submit additional 510(k) filings. The newly cleared cloud deployment option and expanded scanner compatibility also provide health systems with flexibility in how they implement and scale their digital pathology infrastructure.