Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical ...

SpectraWAVE makes technologies to help diagnose and guide treatment decisions for coronary artery disease.

FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...

Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect ...

Combining pulsed field ablation and a radiofrequency technique in one platform is expected to reduce procedure times.

An FDA warning letter about the wearable company’s blood pressure feature raises questions as the lines between medtech and ...

Foresight’s technology will be integrated into Natera’s Signatera platform and is expected to be launched for clinical use in ...

Ben Newton, GE HealthCare’s global head of oncology, said the partnership will shift radiation therapy from a ...

Resmed CEO Mick Farrell will become the next chair of AdvaMed’s board of directors. Farrell will serve a two-year term ...

After introducing its robot in multiple countries outside the U.S., including India, the company turns its focus to the world ...

With the U.S. authorization for urologic procedures, “there is now choice” for hospitals that want to expand their robotic ...

After initially delaying a vote, ACIP backed a softer stance that dissenting members warned would cause harm to children in ...