The US Food and Drug Administration (FDA) has granted 510(k) clearance to PathAI for its digital pathology image management system, AISight Dx, to be used in primary diagnosis in clinical settings.
This clearance builds on the initial approval of AISight Dx (Novo) in 2022.
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AISight Dx has received FDA clearance (K243391) for diagnosis with the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners.
It is also CE in vitro diagnostic (IVD)–marked for primary diagnosis in the UK, the European Economic Area (EEA), and Switzerland.
The agency’s latest decision included a Predetermined Change Control Plan (PCCP), which enables the company to implement major updates to AISight Dx such as scanners, new displays, file formats, as well as browsers, without the need for additional 510(k) submissions.
This alignment paves the way for quicker software and hardware advancements while maintaining compliance with the agency’s regulations.
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By GlobalDataAISight Dx claims to aid laboratories in expediting response times and improving pathologist productivity.
The system’s integrated image management, synchronised multi-slide navigation, and annotation tools aim to eliminate manual processes and facilitate quicker diagnostic outcomes.
AISight Dx enables anatomic pathology labs, academic medical centres, and hospital systems to update their operations and provide quality patient care.
It is said to support real-time partnership, allowing both synchronised and asynchronous slide review, expert consultations, and educational opportunities in a user-focused environment.
PathAI CEO Andy Beck said: “Digital pathology is the future of diagnostic medicine, empowering pathologists to work more efficiently and collaborate quickly without being limited to physical specimen review.
“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.”
This February, the company introduced the PathAssist Derm AI tool, aimed at orienting, detecting, and measuring skin lesions.
