Just 61% of hospitals surveyed evaluated models for accuracy on their own data, and less than half evaluated the models for ...

Spencer’s arrival at Eko comes months after the digital health company appointed his former colleague Brent Lang to its board ...

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

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

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 ...

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

McKinsey data shows that over a 10-year period, supply chain shocks could cost a medical device company 38% of a typical year ...