FDA 510(k) clearance

mint Lesion™ technology receives FDA 510(k) clearance and is now widely available to the North American market

mint Lesion™, distributed by Translational Sciences Corp. (TSC) in the United States under the brand name OncoTrac™, has received 510(k) clearance from the U. S. Food and Drug Administration (FDA) as a class II medical device, and becomes a commercially available solution for clinical research and patient care in the United States.

The mint Lesion™ technology is designed to assure conformity to response assessment standards and to aid compliance with established clinical research standards including FDA Good Clinical Practice (GCP) and Part 11 Electronic Medical Records.