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

Swan highlighted Todd’s experience in scaling robotic platforms, building global engineering organizations and driving ...

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 ...

Part of the money will go toward setting up a joint venture in Qatar, whose sovereign wealth fund led the round.

The IsoPSA test is intended to help assess whether patients with elevated PSA levels should go on to receive a biopsy ...

AdvaMed supports the legislation, which is intended to ensure AI-enabled devices receive an accurate CMS payment code.

As of Oct. 1, Olympus had reported 113 serious injuries and no deaths associated with problems releasing or detaching its ...

Jeb Denny started at Medtronic on Tuesday in the company’s acute care and monitoring business, which makes pulse oximeters, ...

Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating ...

By acquiring new accounts and expanding into NICUs managed by existing clients, Ceribell calculates it can unlock a $400 ...

BD has written to users of its Alaris pump modules about a risk associated with two complaints of serious injury. The Food ...