meeting with the U.S. Food and Drug Administration ("FDA") on December 17, 2024, regarding its 510(k) premarket filing submission for the Company's mBôs TKA System (the "Application").

today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Cohealyx ™, a new collagen-based dermal matrix branded by AVITA Medical and co-developed with ...

Accelerate Diagnostics, Inc. (Nasdaq: AXDX) (Accelerate), an in vitro diagnostics company dedicated to providing services ...

Accelerate Diagnostics, Inc. (Accelerate), an in vitro diagnostics company dedicated to providing services that improve patient outcomes and lower healthcare costs through the rapid diagnosis of ...

Moreover, even with a validation plan accepted by the FDA, there are many more months of work to be completed before the company can submit a formal 510(k). 5) Commercial risks From the outset ...

Inogen (INGN) announced that it has received U.S. Food and Drug Administration FDA 510(k) clearance for the SIMEOX 200 Airway Clearance ...

Inogen, Inc., a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ventris Medical’s Backpack (Porous Biologic ...

Monday announced that the company has received U.S. Food and Drug Administration 510(k) clearance for the SIMEOX ...

Medical device manufacturers seeking global market access often prioritize the U.S. Food and Drug Administration (FDA) ...

This shift is driven by the current political scenario and the China plus one strategy, leading to an increase in US FDA inspections across India. According to the FDA's FY 2023 Annual Report, the ...