Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of neurological and physical medicine devices, which is in charge of regulating ...

Live Science spoke with Dr. Joe Alexander of NTT Research about "digital twins" and the development of an autonomous device ...

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

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

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 ...

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

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...

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 ...

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 ...

(TNS) — Every day millions of people share more intimate information with their accessories than they do with their spouse. Wearable technology — smartwatches, smart rings, fitness trackers and the ...

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 ...