Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for its first software-as-a-medical-device solution.
The 4D Q-plasia OncoReader Breast provides histopathologists with an adjunct technology to improve diagnostic accuracy of breast cancer features (e.g., its invasiveness, grades, etc.) solely from digitised histopathology images obtained via biopsies or resections, demonstrating promise of significant improvements over the existing standard of care.
