HeartBeam (NASDAQ: BEAT) was among the medical device companies highlighted in a Jan. 8 report by Modern Healthcare by Lauren ...

Octapharma has received approval from the US Food and Drug Administration (FDA) for a new 2-gram (g) formulation of Fibryga ...

The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.

W. L. Gore & Associates has secured FDA approval for the GORE VIABAHN FORTEGRA Venous Stent — previously known as the GORE ...

Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a ...

Stereotaxis plans to launch the MAGiC cardiac ablation catheter in early 2026, CEO and Chair David Fischel tells MassDevice.

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...

The Bethlehem-based maker of at-home diagnostic tests said it submitted two separate applications to the FDA at the end of ...

The Food and Drug Administration may toughen is approval process for 510(k) clearance for medical devices, according to a report by the Wall Street Journal. The move causes concern for medical device ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as recent layoffs have reportedly had ...