BOSTON, June 30, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight® Dx*—its digital pathology image management system—for use in primary diagnosis in clinical settings. Building on the initial 510(k) clearance for AISight Dx(Novo) in 2022, this latest milestone underscores the platform’s continuous innovation and PathAI’s commitment to delivering enhanced capabilities as the product evolves.
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The digital pathology market is segmented by product type into scanners, storage systems, and software. In 2024, scanners led the segment due to their pivotal role in converting glass slides to digital images, enhancing remote diagnostics. Human pathology is forecasted to dominate during the period, driven by global chronic disease burdens, necessitating accurate diagnostics. The rise of AI and machine learning in processing digital images boosts efficiency and diagnostic precision. North America is set to lead the market, fostered by a supportive regulatory framework and financial backing for innovation. Key players include Danaher, Philips, and F. Hoffmann-La Roche, among others. This comprehensive report provides in-depth insights into market drivers, opportunities, and competitive assessments across regions.
The digital pathology market is segmented by product type into scanners, storage systems, and software. In 2024, scanners led the segment due to their pivotal role in converting glass slides to digital images, enhancing remote diagnostics. Human pathology is forecasted to dominate during the period, driven by global chronic disease burdens, necessitating accurate diagnostics. The rise of AI and machine learning in processing digital images boosts efficiency and diagnostic precision. North America is set to lead the market, fostered by a supportive regulatory framework and financial backing for innovation. Key players include Danaher, Philips, and F. Hoffmann-La Roche, among others. This comprehensive report provides in-depth insights into market drivers, opportunities, and competitive assessments across regions.