Inspirata announced today that it received FDA clearance for its Dynamyx digital pathology software.
Tampa, Florida-based Inspirata’s Dynamyx software platform allows for the use of whole slide images (WSIs) for primary diagnosis in place of traditional glass slides.
According to a news release, Inspirata’s regulatory win marks the first FDA clearance for digital pathology software with multiple scanners, giving customers an open platform that allows for the selection of the best scanners for their laboratory.
The Ohio State University’s Wexner Medical Center Vice Chair of Anatomic Pathology Dr. Anil Parwani said in the release that FDA clearance will “pave the way for more clinical adoption of digital pathology,” as well as for AI tools for clinical application, teaching, education and research.
Parwani added that the software includes an intuitive user interface with many annotation tools, a universal viewer and customizable third-party AI applications to be made available as needed by the pathologists.
“Inspirata 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,” Inspirata EVP and Founder Mark Lloyd said. “We are immensely proud of our hard work leading up to this achievement and believe that FDA clearance is critical for all vendors for the long-term success of the industry.”