Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical d

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. Thi