Latest news with #LeicaAperioGT450DX
Yahoo
01-07-2025
- Business
- Yahoo
PathAI's digital pathology image management system gains FDA clearance
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. 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. AISight 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. "PathAI's digital pathology image management system gains FDA clearance" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Miami Herald
21-05-2025
- Business
- Miami Herald
CORRECTING and REPLACING: Tribun Health Achieves FDA Clearance for CaloPix Digital Pathology Platform With Dual Scanner Compatibility
[CORRECTED RELEASE] Updated to clarify reference to dual-scanner FDA clearance. PARIS, FRANCE / ACCESS Newswire / May 21, 2025 / Tribun Health, a leader in digital pathology, proudly announces that its flagship web-based image management system, CaloPix®, has received FDA 510(k) clearance for use with two leading whole slide imaging scanners: the Hamamatsu NanoZoomer S360MD and the Leica Aperio GT450 DX. This double clearance is representing a major step forward for the U.S. adoption of vendor-agnostic, enterprise-grade solutions. This clearance builds on CaloPix's strong regulatory track record: the solution is CE-marked, Health Canada-approved, and trusted by more than 100 hospitals and laboratories across Europe and Canada. With over 1,000 active users of CaloPix® worldwide, this milestone underscores the platform's scalability, performance, and rapid adoption across diverse healthcare systems. Now, with FDA clearance secured, Tribun Health is ready to bring its proven enterprise solution to hospitals and labs across the United States. Besides these regulatory achievements, CaloPix® has also been recognized three times as "Best in KLAS" for digital pathology, a global benchmark for excellence in healthcare IT. This prestigious recognition highlights Tribun Health's commitment to customer satisfaction, operational excellence, and product innovation. "This is a major commercial and clinical milestone for us," said Jean-François Pomerol, CEO of Tribun Health. "We're entering the U.S. with a solution that has already proven its value in demanding, high-throughput clinical environments. With CaloPix®, we offer a platform trusted by top-tier institutions, awarded Best in KLAS multiple times -and now validated by the FDA. As the market accelerates toward widespread clinical adoption, we're thrilled to expand our reach and solidify our position as a truly global player." Built for Enterprise, Designed for Performance, Ready for Cloud CaloPix® goes far beyond a traditional image viewer-it's a powerful, all-in-one digital pathology platform tailored for the needs of modern healthcare systems, large hospital networks, and academic institutions. Key capabilities include: Web-based, cloud-ready, zero-footprint architecture-no local installation required High-throughput case management and diagnostic reporting to streamline daily workflowsSeamless integration with LIS and VNA systems for unified data access across the enterpriseBuilt-in telepathology and remote collaboration tools for second opinions and network-wide consultationsArchiving, export, and quality control features to support regulatory compliance and research initiatives Meeting the Moment: Solving U.S. Market Challenges The U.S. faces a growing mismatch between rising pathology case volumes and a shrinking workforce. At the same time, there is a clear push for multi-site collaboration, integrated diagnostics, and precision medicine initiatives. With this FDA clearance, CaloPix® empowers U.S. hospitals and labs to: Digitize pathology workflows at scaleReduce turnaround times and improve reporting accuracyCollaborate remotely across institutionsPrepare for AI adoption with structured, interoperable data Building on our success with public health networks, cancer centers, academic hospitals and private laboratory groups across Europe and Canada, we are now ready to scale in the world's largest healthcare market-the United States. * CaloPix® is CE-marked, Health Canada-approved, and FDA 510(k) cleared. Please refer to the Instructions for Use (IFU) for intended purpose and regulatory indications. About Tribun Health Tribun Health is a global leader in digital pathology, offering award-winning solutions that improve workflow efficiency, diagnostic accuracy, and patient outcomes. We assist hospitals and laboratories in transitioning from glass slide pathology to fully digital solutions, leveraging AI and data-driven technology to enhance precision and reduce turnaround times. Our mission is simple: to ensure every cancer patient receives a timely and informed diagnosis-because every moment counts. By advancing pathology with cutting-edge innovations, we are shaping the future of cancer care. For more information, visit Tribun Health and follow us on LinkedIn and X. SOURCE: Tribun Health press release
