FDA Grants 510(k) Clearance to Inspirata for Its Digital Pathology Software

Tampa, Fla.-based Inspirata has received the FDA’s 510(k) clearance for its Dynamyx digital pathology software for analysis of slide images.

In response to the COVID-19 pandemic in early 2020, the FDA granted a temporary waiver of 510(k) requirements that allowed Dynamyx to be used for primary diagnosis without the need of a 510(k) clearance.   

Mark Lloyd, Inspirata’s founder and executive vice president, explained that the company “recognizes our customer’s 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.”

The open platform software works on a wide range of scanners, allowing pathologists and laboratories to select the most suitable scanner for their purposes.