PathAI Receives Both FDA 510(k) Clearance and CE Mark for AISight Dx Platform

The two milestones represent major developments in the company’s mission to improve patient outcomes with AI-powered pathology.

BOSTON – August 12, 2022, PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, today announced two milestones that significantly support its mission to improve patient outcomes. First, PathAI received 510(k) clearance from the US Food and Drug Administration (FDA) for AISight Dx, a digital pathology platform for the purpose of primary diagnosis in clinical settings. Second, AISight Dx is CE Marked for in-vitro diagnostic (IVD) use in the European Union (EU), designating conformity with European health, safety, and environmental protection standards. These designations pave the way for IVD use of AISight Dx with the Philips Ultra Fast Scanner in the US and the EU.

AISight Dx is a lightweight, web-based digital pathology slide viewing platform that enables the management and review of whole slide images (WSIs) and will accelerate access to AI-powered algorithms’ quantitative and visual outputs. AISight Dx was designed based on input from hundreds of external pathologists in laboratories worldwide as well as from staff at PathAI Diagnostics, PathAI’s anatomic pathology laboratory. The platform is validated to ensure the highest quality image resolution for clinical IVD use.

“This clearance marks a significant milestone for PathAI as it opens the door for the use of this platform and future algorithms in a clinical setting, including CDx and IVDs developed in collaboration with our biopharma customers,” said Andy Beck, Co-founder and CEO of PathAI. “Combining the use of AISight Dx and — soon — access to PathAI’s large and rapidly expanding algorithm library, we can better support clinical decision making. Providing a validated viewer and IMS platform was a critical first step to establishing a large menu of clinically relevant algorithms. These advancements bring us closer to achieving our mission of improving patient outcomes with AI-powered pathology.”

AISight Dx is a standalone viewer that can interoperate with existing manual and digital pathology workflows. Because of this flexibility in use, AISight Dx will be simple for pathologists to deploy into existing workflows. Additionally, AISight Dx can enable pathologists who are working remotely to collaborate more seamlessly to drive fast turnaround times for patients and improve patient outcomes.

“There could not be a more paramount time for PathAI to introduce a cleared viewer for pathology. Given the recent publication of digital pathology CPT codes, we believe more labs will be embracing digital pathology,” said Jim Sweeney, president of PathAI Diagnostics and a 20+ year veteran of the anatomic pathology industry. “We’ve been providing digital pathology for years; we know that the addition of AISight Dx to our platform will tremendously impact our ability to have both primary diagnosis and access to PathAI’s growing algorithmic model capabilities.”

In addition to AISight Dx, PathAI has developed AISight that can be used by biopharmaceutical companies, contract researchers, academic institutions, and physicians to support AI-driven research.* Those researchers engaged in exploratory and clinical drug development research can leverage this platform specifically for regulated (GxP) clinical trials or translational research.

 

*AISight is for research use only. Not for use in diagnostic procedures.