regulatory
confidence high
sentiment positive
materiality 0.65
Biomerica submits final H. pylori dataset to FDA for 510(k) review of hp+detect test
BIOMERICA INC
- Submitted final H. pylori data-set to FDA on Sep 15, 2023, as requested during FDA's 510(k) review.
- FDA confirmed receipt of the data; Biomerica's hp+detect test detects H. pylori bacteria.
- H. pylori infects approximately 35% of the U.S. population.