Tampa, Florida / GlobeNewswire – Digital pathology and cancer informatics provider Inspirata announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its Dynamyx digital pathology software. This clearance enables Dynamyx customers to use whole slide images (WSIs) for primary diagnosis in place of traditional glass slides, yielding an array of powerful benefits to pathologists and laboratories.
Dynamyx holds the first FDA clearance for digital pathology software with multiple scanners. This highlights Inspirata’s core commitment to a scanner agnostic and open platform that will allow its customers to select the best scanners for their laboratory.
“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.”
Access our special Content Hub for more information on the significance of the FDA clearance for Dynamyx: https://inspirata.link/FDA-cleared.
Inspirata, Inc. helps patients fighting cancer—and the clinicians they trust—to make every moment matter. Our comprehensive cancer informatics solutions bring disparate data together throughout the entire cancer care journey to drive informed decisions that improve survivorship.
Inspirata has assembled the most advanced and proven technologies to address the complex challenges of delivering cancer care and conducting ground-breaking research. We combine leading digital pathology solutions with automated cancer registry solutions, comprehensive cancer informatics and advanced patient engagement tools to bring users the broadest oncology informatics platform available globally. To learn more, visit www.inspirata.com.
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