FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

Samsung plans to showcase a Brain Health feature at CES 2026 that uses wearable and smartphone data to flag early dementia ...

Smartwatches and wearable heart monitors can help detect issues such as irregular heart rhythms. But they also have limits and do not replace a diagnosis.

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 ...

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 ...

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

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 ...

Medical device makers are seeking an exemption from Donald Trump's tariffs they say will raise the price of their products and devastate the medical device and medical technology industry. In this ...

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 ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or death ...

Why Are Nanomaterials Used in Medical devices? Medical devices have become an essential part of daily life and represent an expanding market. Applications for medical devices range from diagnostic ...