Sectra receives FDA clearance for digital pathology solution

Sectra, an international medical imaging IT and cybersecurity company based in Sweden, has received FDA clearance for its Digital Pathology Module, a primary diagnostics tool intended for U.S. healthcare providers.

The solution could be key in complex cancer cases and is already in use in the U.S. for research and tumor boards.

“I’m excited that with the FDA approval, 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,” Mikael Anden, president of Sectra, said in a statement. “Our solution makes it possible for pathologists across the country to continue their important work from home without the need for a microscope.

The digital pathology solution can give physicians instant access to current and historical images and related data with digital tools to review the images. That’s an improvement from viewing tissue samples on physical glass slides. Digital access also makes it easier to gain second opinions, remote reading, specialist consultation and integrated diagnostics, according to Sectra.

“Pathology is the next huge digitization of healthcare,” Torbjörn Kronander, president and CEO of Sectra, said in a statement. “The use of glass slides limits growth in today’s increasingly digital environment, especially in consolidated health care systems where potential synergies cannot be reached unless pathology is digitized. Our solution opens up new opportunities in the [U.S.] where we can point to our successes in Europe in large production centers.”

All of Sectra’s enterprise imaging offerings, including this digital pathology solution, are on the same technical platform, allowing healthcare providers to use a single solution for their medical imaging needs. The platform can enable integrated diagnostics in complex cases where both radiology and pathology play roles.

“We look forward to providing uninterrupted pathology reading in these challenging times,” Anden said. “This approval is an exciting and important step forward for pathology and cancer care in the US.”