Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...
FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
BlueOcean Global Corp., a medical device company focused on limb preservation and complex reconstruction, today announced U.S ...
After receiving word late last month that the FDA would not be issuing a 510(k) clearance to its cable-free electrocardiogram, HeartBeam has successfully appealed the decision and now touts a green ...
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S.
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that the U.S. Food and Drug ...
Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND) application for its drug AXN-2510 by the FDA, enabling the company to begin a phase 1 trial before the end of 2025. This ...
Paragonix Technologies Receives FDA 510(k) Clearance for KidneyVault Portable Renal Perfusion System
WALTHAM, Mass.--(BUSINESS WIRE)--Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, received U.S. Food and Drug Administration (FDA) 510(k) clearance ...
A San Diego company has earned FDA clearance for a device that could make blood testing easier. Truvian Health’s device, TruVerus, uses a small amount of blood to return routine tests quickly. The ...
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