Digital pathology software developer Inspirata has secured an FDA clearance for its tissue slide analysis program that can be used with multiple scanners.
This allows pathologists using the company’s Dynamyx software to rely on whole-slide images for delivering a primary diagnosis instead of the traditional glass sample slides. According to Inspirata, a more open, scanner-agnostic platform can permit pathology laboratories to select the best hardware that suits their needs.
At the same time, the company said its universal slide viewer can be customized with third-party applications such as artificial intelligence programs for highlighting tissues suspected of harboring cancer cells or automatically counting and measuring cells of different types.
The system also provides for real-time second opinions, allowing pathologists to collaborate virtually while viewing the same slide.
Inspirata’s software has been available since January 2021, after the FDA announced it would temporarily waive the requirements for some digital programs to obtain a 510(k) clearance during the COVID-19 pandemic.
The agency aimed to quickly promote the use of a range of remote technologies in health systems—not just for monitoring patients outside the hospital but also for allowing pathologists to complete their work in more of a social distancing manner or from the safety of their own homes.
“With less regulation, the government is agreeing that digital pathology is more comparable to the traditional microscope and glass in terms of safety and efficacy,” Mark Lloyd, Inspirata’s founder and executive vice president, said in a statement at the time. “This is a great attestation of the maturity that digital pathology has reached.”
Regardless, Inspirata spent the past year pursuing a full FDA clearance in recognition of its customers’ desire for the agency’s assurance, Lloyd said.