Biovica: 510 (k) Submission Completed

Research Note

2020-09-25

11:37

Redeye is encouraged by Biovica's filing of a 510 (k) submission to the FDA for market clearance of the DiviTum test. Following the successful analytical and clinical validation completed during the summer, we had expected this step. We do not make any changes to our valuation at this point, anticipating the FDA's decision whether the regulator accepts to review the application (normally within a month).

NE

Niklas Elmhammer

Disclosures and disclaimers

Premium Plan required to unlock

Unlock companies to access

more high quality research.