Inspirata Receives Industry’s First FDA Clearance for Scanner Agnostic Digital Pathology Software

“FDA clearance for Inspirata’s Dynamyx software is exciting, as this will pave the way for more clinical adoption of digital pathology and AI tools for clinical applications, as well as teaching, education, and research,” said Dr. Anil Parwani, Vice-Chair of Anatomic Pathology at the Ohio State University’s Wexner Medical Center. “As a current user of Dynamyx, I am looking forward to using the intuitive user interface with the many annotation tools, universal viewer, and customizable third-party AI applications that can be made available as needed by the pathologists.”

In response to the COVID-19 pandemic in early 2020, the FDA and CMS announced temporary waivers of 510(k) requirements and CLIA licensing requirements, allowing Dynamyx to be used for primary diagnosis without the need of a 510(k). Despite this waiver, Inspirata pursued FDA clearance as part of its commitment to the rigor and discipline instilled by the country’s regulatory bodies.

“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,” said Mark Lloyd, Executive Vice President and Founder of Inspirata. “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.”