Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of ...

Smartwatches and wearable heart monitors can help detect issues such as irregular heart rhythms. But they also have limits ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...

The Illinois lawmakers want an electronic format for medical device makers to quickly and transparently report recall ...

The Food and Drug Administration (FDA) issues recalls for thousands of medical devices yearly due to safety issues. In January 2024, the Government Accountability Office (GAO) formally accepted a ...

A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say ...

Lawmakers requested the report after a 2023 ProPublica and Pittsburgh Post-Gazette investigation revealed that the FDA had ...

In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...

A new device called Barostim is helping heart failure patients at Christ Hospital in Cincinnati live more normal lives ...

Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.

OAKLAND, Calif. (KGO) -- As we continue to navigate the tripledemic of COVID-19, RSV, and the flu, local health leaders are raising concerns over a key medical device that often determines if a sick ...

In the medical device industry, there are many ways of measuring success. To be sure, most company leaders take greatest pride in the number of patients whose health has been improved through the use ...