Sectra, Linköping, Sweden, has received an FDA 510(k) clearance for the Sectra digital pathology module when used together with Leica Biosystems’ AT2 Dx scanner. The agency’s clearance enables US healthcare providers to use Sectra’s digital pathology solution for primary diagnostics.
“I’m excited that with the FDA clearance, we are now able to offer US healthcare providers a digital pathology offering with a proven track record of use for full-scale primary diagnostics and large volumes,” says Mikael Anden, president of Sectra. “Our solution makes it possible for pathologists across the country to continue their important work from home without the need for a microscope. We look forward to providing uninterrupted pathology reading in these challenging times. This approval is an exciting and important step forward for pathology and cancer care in the United States.”
Sectra’s digital pathology solution is already used in the United States for research and tumor boards. With digital images of tissue samples instead of physical glass slides, pathologists gain instant access to current and historical images and related data as well as to digital tools for reviewing the images. Digital access also facilitates efficient second opinions, remote reading, and specialist consultations, and it makes integrated diagnostics possible.
For more information, visit Sectra.