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

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

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

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

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

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

Ryan Weispfenning has elected to take up the challenge of creating and leading the investor relations function at the planned ...

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

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

The partnership is the first time Medtronic has integrated its insulin pumps with a sensor developed outside of the company.

Although the strategy is internally focused to start, the agency said it will collaborate with the private sector and ...

J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the ...