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Hamamatsu Expands Digital Pathology Lineup with Two FDA Clearances

Clinical pathology laboratories in the United States now have expanded access to digital imaging tools following FDA 510(k) clearance for Hamamatsu Photonics' NanoZoomer S20MD and S540MD slide scanner systems, diversifying the company’s portfolio to cover both compact benchtop needs and high-volume, high-throughput laboratory operations.

Hamamatsu Expands Digital Pathology Lineup with Two FDA Clearances
Photo: Bio & News

These two additions join the previously cleared NanoZoomer S360MD to form a unified platform. By integrating the compact S20MD for smaller footprints and the high-capacity S540MD for demanding workflows, Hamamatsu aims to provide a consistent user experience across varied laboratory environments. The company emphasizes that the new systems maintain the image quality and long-term reliability associated with the legacy NanoZoomer series.

Scott Blakely, Business Development Manager for the Americas, described the clearances as a pivotal step in the firm’s strategy to scale its presence in the U.S. clinical market. This move allows facilities to select hardware tailored to their specific operational scale while remaining within a singular, validated ecosystem.

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