Mainz BioMed Seeks FDA Breakthrough Device Designation for Advanced Colorectal Cancer Test
Mainz BioMed CEO submits application to FDA for Breakthrough Device Designation for innovative colorectal cancer screening product incorporating mRNA biomarkers. Strong clinical study results support the regulatory submission.
This news matters as the Breakthrough Device Designation could accelerate the approval process for an innovative non-invasive colorectal cancer screening product, potentially benefiting early cancer detection efforts.