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.
- 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.
- While Inspirata has been in the process of obtaining 510(k) clearance from the FDA, the temporary waiver has allowed Dynamyx to be used for primary diagnosis since the waivers issuance in 2020.
- However, the newly proposed permanent waiver would allow Dynamyx to be used for primary diagnosis in perpetuity without the need of a 510(k).
- In fact, Digital Pathology Image Viewing and Management Software registered zero adverse effects during that time.