For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...

A Unique Device Identifier (UDI) is an individualized alphanumeric signature associated with a single medical device. Since 2013, the Food and Drug Administration (FDA) has mandated the placement of ...

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 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 ...

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 ...

Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the ...

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 ...

The Association of Indian Medical Device Industry said it strongly opposes any move to reconsider or relax policy restrictions on importing refurbished or pre-owned medical equipment, especially ...

Fueled by convenience, fashion, size and technical innovation, medical devices have evolved from clinical settings to daily consumer use. Today’s highly personalized devices are being embedded into ...