MedTech News

FX Shoulder Solutions, Inc. Receives FDA 510k Clearance for Full-Wedge Augmented Glenoid Baseplates

ADDISON, Texas , May 16, 2024 /PRNewswire/ — FX received 510k clearance for its full-wedge augmented glenoid baseplates. The newly cleared baseplates bring 6 new options to the previously cleared portfolio. There are now a combined total of 18 glenoid baseplate options to the market to address a variety of surgeon needs. Augmented glenoid baseplate options have continued to become a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid.

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FDA Grants EUA to Wondfo’s WELLlife™ COVID-19/Influenza A&B Test Supported by DCN Dx Clinical Research

CARLSBAD, Calif., May 15, 2024 /PRNewswire/ — DCN Dx, a leading contract research organization for in vitro diagnostics, today acknowledges the FDA’s Emergency Use Authorization (EUA) of the WELLlife™ COVID-19/Influenza A&B Test, developed by Wondfo USA. This important authorization will enable healthcare professionals to differentiate rapidly between COVID-19 and influenza infections, enhancing patient care at the point-of-care.

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