nor restrict the company’s ability to seek FDA 510(k) clearance of new products. The company takes the matters identified in the warning letter seriously, has already submitted several responses ...

The letter did not raise any concerns regarding clinical safety or efficacy data. The Food and Drug Administration (FDA) has issued a Complete Response Letter to Milestone Pharmaceuticals ...

EYSINS, Switzerland, April 3, 2025 /PRNewswire/ --Today, AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex ...

MARCY L'ÉTOILE, France, March 18, 2025 /PRNewswire/ --bioMérieux, a world leader in the field of in vitro diagnostics, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance for ...