ECRI, the patient safety organization, has published its annual list of the 10 health technology hazards it's watching in 2024. As part of its safety-focused mission, the nonprofit ECRI conducts ...

Recalls of home-based medical devices and defective single-use devices are the top two concerns on the Pennsylvania-based non-profit's top 10 technology hazards for 2023. The growing popularity of ...

All medical devices have risk. “You, as the manufacturer, are responsible for determining the risk of your medical device and if that risk is acceptable,” said Joseph Tartal, FDA deputy director in ...

Furthermore, medical device security system provides various benefits, which include customized security to each device, integrated security system in each device, secure communication channel between ...

More than 3 million Americans with pacemakers depend on these chemicals to live.

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, ...

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 ...

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 ...