Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

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

Octapharma USA, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new 2-gram presentation ...

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

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

The MAGiC catheter is designed to perform minimally invasive cardiac ablation procedures that treat various forms of ...

The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.

FDA approves first venous stent for IVC and iliofemoral veins, offering a new treatment for deep venous disease with proven 12-month patency.

Abbott’s Volt pulsed field ablation system — for the treatment of atrial fibrillation. The Volt system delivers high-energy electrical pulses to targeted areas of the heart to disrupt abnormal rhythms ...

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 ...

OraSure TechnologiesOSUR recently announced that it submitted two applications to the FDA seeking approval for its two new at ...

Rakuten Medical has added to its tally of mega-rounds, pocketing another $100 million to push its lead light-based cancer ...