Proposed FDA Regulatory Flexibilities Permit Primary Diagnosis with Inspirata’s Dynamyx Digital Pathology Solution
Cancer informatics and digital pathology provider Inspirata announced today that pandemic-related regulatory flexibilities issued by the U.S. Food and Drug Administration (FDA) may enable Inspiratas digital pathology solution, Dynamyx, along with other digital pathology components to be used for primary diagnosis in perpetuity, without the need for 510(k) premarket notification.