PathAI received FDA 510(k) clearance for AISight Dx platform in the United States.
PathAI, a Boston-headquartered AI company with 450 pathologists in its network, secured a vital approval from the US Food and Drug Administration (FDA) for its diagnosis software.
Its AISight Dx platform is designed to streamline the analysis of biological lab slides and improve productivity.
“Digital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review," said CEO Andy Beck.
Already CE-marked in Europe, the platform is positioned to support hospitals, academic centres and diagnostic labs looking to modernise their pathology workflows.
With an FDA '510(k) clearance' PathAI can now advance AISight Dx platform in the United States also.
“This 510(k) clearance showcases our commitment to quality and scientific rigor at PathAI and provides us a way forward to continually enhance our AISight Dx IMS,” Andy Beck added.
