Norm has received breakthrough device designation from the Food and Drug Administration, giving Fire1 additional access to the agency as it works to bring the product to market. The early feasibility ...

After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued ...

The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for ...

The deal for Bolt, developer of an intravascular lithotripsy system to treat coronary and peripheral artery disease, ...

Stifel analyst Rick Wise said the financing, a combination of private stock placement and new loans, should help the dialysis ...

The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and ...

Stryker made several small deals last year but lacked a larger acquisition like its nearly $5 billion proposal for Inari ...

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are ...

Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.

The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...

Stefan Kaufmann, former CEO of Tokyo-based Olympus, stepped down in October after the company investigated an allegation that ...