NEW YORK – Inspirata said Tuesday that the US Food and Drug Administration has cleared its Dynamyx digital pathology software, allowing customers to use whole-slide images for primary diagnosis rather than traditional glass slides.
Tampa, Florida-based Inspirata sought the FDA clearance despite the agency's temporary waiver of 510(k) requirements during the COVID-19 pandemic.
"Inspirata recognizes our customers' desire to have the assurance of an FDA market clearance. We are confident that this significant milestone will help our customers communicate the maturity of digital pathology across their organization," Mark Lloyd, Inspirata's executive VP and founder, said in a statement.
Anil Parwani, vice chair of anatomic pathology at Ohio State University's Wexner Medical Center, added that the FDA clearance will lead to the increased adoption of digital pathology and artificial intelligence in clinical, educational, and research settings.
Inspirata inked a distribution deal for Dynamyx with Fujifilm in 2020 and a technical partnership with Augmentiqs covering the software the same year.