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- PathPresenter has received FDA 510(k) clearance for its Clinical Viewer platform, enabling primary diagnosis using digital pathology workflows. - The clearance is specifically for use with Hamamatsu NanoZoomer S360MD slide scanners and Barco NV MDPC-8127 display devices. - The platform addresses a critical need in healthcare, as pathology guides nearly 70% of clinical decision-making processes. - This regulatory milestone advances the adoption of digital workflows in pathology and supports precision medicine initiatives.
- PathAI announced FDA 510(k) clearance for its AISight Dx digital pathology platform for primary diagnosis in clinical settings, building on initial clearance received in 2022. - The FDA decision includes a Predetermined Change Control Plan (PCCP) that allows PathAI to implement major changes like additional displays, scanners, and file formats without requiring new 510(k) submissions. - AISight Dx is a cloud-native platform designed to modernize anatomic pathology workflows through intelligent case management, high-performance slide review, and seamless collaboration capabilities. - The platform is FDA-cleared for use with Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners, offering interoperability for organizations of any size.
- Paige has received FDA Breakthrough Device designation for PanCancer Detect, the first AI application designed to identify cancer across multiple tissue types and organs, addressing the growing pathology workforce shortage. - The company recently secured additional FDA 510(k) clearance for its FullFocus digital pathology viewer with Leica Aperio GT 450 DX and Hamamatsu NanoZoomer S360MD scanners, expanding its regulatory portfolio. - Paige continues to lead in AI pathology innovation, having previously developed the first FDA-authorized AI application in pathology and the first million-slide foundation model for cancer detection.
