XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study ...
A popular medical monitor ... health care risk, it extends to a range of medical equipment produced overseas. Cash-strapped U.S. hospitals, he explained, often buy medical devices from China ...
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
Billions of Devices at Risk of Hacking & Impersonation Due to ... laptops, smart locks, and medical equipment. Its popularity is partly due to its low cost, with units available for just a few ...
A brain implant designed to help control seizures is hijacked. A pacemaker receives fake signals, disrupting its rhythm. A ...
The agency changed course just days after firing employees who oversee the safety of food and life-sustaining medical devices. Dozens of workers said they and others were back at work Monday.