Sectra gains FDA clearance for digital pathology diagnostic, remote reading module

Medical imaging company Sectra has received U.S. Food and Drug Administration clearance for its digital pathology solution that enables pathologists to view images at home.

The firm’s Digital Pathology Module is part of Sectra’s overall pathology solution. And in light of the April 1 announcement, U.S. providers can now use the tool to view pathology slides side-by-side with medical images, facilitate second opinions and work remotely without traditional microscopes.

“I’m excited that ... we are now able to offer U.S. healthcare providers a digital pathology offering with a proven track record of use for full-scale primary diagnostics and large volumes,” Sectra President Mikael Anden said in a statement. “We look forward to providing uninterrupted pathology reading in these challenging times.”

The Sweden-based company’s digital module was already being used in the U.S. for research and tumor board purposes. This April 1 clearance allows clinicians to use it with Leica Biosystems’ scanner AT2 DX, according to the statement.

“Pathology is the next huge digitization of healthcare,” said Torbjörn Kronander, PhD, president and CEO of Sectra. “The use of glass slides limits growth in today’s increasingly digital environment, especially in consolidated healthcare systems where potential synergies cannot be reached unless pathology is digitized.”