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INFINITT North America Expands Digital Pathology Portfolio with FDA-Cleared Hamamatsu S360MD Scanner Integration


News provided by

INFINITT North America

Dec 18, 2025, 14:00 ET

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INFINITT North America, a leader in advanced healthcare imaging solutions, is excited to announce the newest addition to its digital pathology platform: the FDA-cleared Hamamatsu NanoZoomer S360MD Slide Scanner, now seamlessly integrated with the INFINITT Digital Pathology Solution (DPS). This milestone solidifies INFINITT's position among the digital pathology sector's top innovators and signals a new era of practical, flexible imaging for U.S. hospitals and labs.

PHILLIPSBURG, N.J., Dec. 18, 2025 /PRNewswire/ -- The INFINITT Digital Pathology Solution, FDA-cleared for primary diagnosis of FFPE tissue slides, now supports Hamamatsu NDPI file format through its collaboration. Facilities can leverage existing slide archives and hardware investments; lowering adoption barriers and accelerating the switch to a fully digital workflow—all within current hospital infrastructure.

"This FDA clearance reflects our commitment to helping institutions across the country move forward with digital pathology—not just as a buzzword, but as an actionable, interoperable reality," said David Smarro, CEO for INFINITT North America. "By making leading-edge technology truly accessible, we're powering smarter, faster, and more connected patient care."

"This FDA clearance reflects our commitment to helping institutions across the country move forward with digital pathology—not just as a buzzword, but as an actionable, interoperable reality," said David Smarro, CEO for INFINITT North America.

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Poised for Continued Growth and Innovation

INFINITT isn't just a digital pathology company. With established excellence in radiology, cardiology, ophthalmology, dental imaging, and more, the organization is positioned as a comprehensive imaging partner for healthcare leaders nationwide. The recent FDA clearance is just another step in our comprehensive plan. We're actively developing support for additional scanners and plan to submit these for FDA review in 2026.

About INFINITT North America

Headquarters in Philipsburg, New Jersey, INFINITT North America is a subsidiary of INFINITT Healthcare Co., Ltd., delivering patient-centered imaging solutions with a focus on interoperability, clinical performance, and customer support. INFINITT empowers clinicians to deliver outstanding care through technology that performs with their workflows.

Media Contact

Shannon Spak, INFINITT North America, 1 877-387-6960, [email protected], https://www.infinittna.com/

SOURCE INFINITT North America

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