J&J is pursuing premarket approval for the heart shunt. Although advisory committees provide recommendations to the FDA, the agency makes the final decisions. Following the vote, a J&J spokesperson ...

Stiles has worked at Stryker for 27 years, most recently leading the company’s orthopedics business.

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

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

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

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

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

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

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

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

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

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