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 ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

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 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 ...

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

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 ...

They’ve got some nerve! Vagus nerve stimulators are making waves as a potential way to relax, sleep better and improve gut health. But an expert on the vagus nerve warns that noninvasive VNS devices ...

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 ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

New York Post may be compensated and/or receive an affiliate commission if you click or buy through our links. Featured pricing is subject to change. Now, I know what you’re thinking. “Prostate health ...