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Sectra, Leica Biosystems Get FDA 510(k) Clearance for Digital Pathology Combo

NEW YORK — Swedish medical imaging company Sectra said Monday that the US Food and Drug Administration has granted 510(k) clearance for its digital pathology software together with Leica Biosystems Imaging's Aperio GT 450 DX scanner.

The clearance allows for the use of Sectra's software for image sorting, analysis, and reporting in combination with Leica's Aperio GT 450 DX high-throughput automated digital scanner, which received 510(k) clearance in mid-2019.

The clearance is the first that enables the use of images in the DICOM file format — a technical standard for medical images and related information — in pathology diagnostics, the company noted.

"This FDA [clearance], including DICOM, shows that standardization is possible also within pathology," Sectra President and CEO Torbjörn Kronander said in a statement. "This is an important first step to a reality where healthcare providers can start reaping the benefits of a larger degree of freedom in choosing what hardware and software to combine within pathology."

Sectra began collaborating with Germany's Leica on the digital pathology offering in late 2019.