The NanoZoomer S20MD and S540MD add compact benchtop and high-throughput options to the company’s FDA-cleared digital pathology portfolio.
Hamamatsu Photonics KK has received 510(k) clearance from the US Food and Drug Administration (FDA) for its NanoZoomer S20MD and NanoZoomer S540MD slide scanner systems, according to a press release from the company.
Building on the previously cleared NanoZoomer S360MD, the new clearances expand the availability of the company’s digital pathology systems in the US, providing clinical pathology laboratories with additional options designed to match specific operational requirements.
The addition of the compact benchtop S20MD and the high-throughput S540MD enables the platform to cover a wide spectrum of laboratory workflows, providing a consistent user experience across the entire product family, the company states.
Expanding Digital Pathology Options
With these clearances, the portfolio provides pathology laboratories with options spanning compact benchtop, routine, and high-throughput testing environments.
“The FDA clearances of the NanoZoomer S20MD and the NanoZoomer S540MD represent an important milestone for Hamamatsu as we continue to expand our FDA-cleared portfolio,” says Scott Blakely, business development manager, Americas, in a release. “These clearances reflect our commitment to providing laboratories with a range of solutions that deliver the image quality, reliability, and long-term performance that define the NanoZoomer platform.”
Together, the NanoZoomer S20MD, S360MD, and S540MD systems are designed to support clinical laboratories seeking standardized digital pathology solutions tailored to varying sample volumes and facility sizes.
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