The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ventris Medical’s Backpack (Porous Biologic Scaffold, K240765) for orthopaedic and spinal fusion procedures. Designed to ...

AVITA Medical (RCEL) “announced that the FDA has granted 510(k) clearance for Cohealyx ... reduce treatment timelines, and improve patient outcomes in the treatment of full-thickness wounds.

The FDA granted marketing clearances for infectious disease tests, updates to a digital pathology system, and immunoassays for chronic diseases.

Leveraging gold-standard PCR technology, the cobas liat system claims to deliver outcomes in under 20 minutes.

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").

I am pleased with the growth and accomplishments related to the Company’s key strategic objectives to set a new standard in neurovascular access and delivery,” said Brian Martin, co-founder and CEO of ...

today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SIMEOX 200 Airway Clearance Device, expanding the company’s ability to market and meet the ...

If you continue to have this issue please contact [email protected]. Smith & Nephew received FDA 510(k) clearance of a stemless option for its Aetos shoulder system. The solution is ...

The reagents are meant for measuring aCL and aβ2GP1 antibody levels in human serum to aid the diagnosis of primary and secondary APS.