NPR. the Masima device company created a Patient Safety Movement Foundation but didn’t investigate reports that its devices harmed patients. “When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible,” Zuckerman said. “Especially when users made complaints that the company’s product put patients at risk,” she said.
The Wall Street Journal. The majority of moderate- to high-risk medical devices approved by the U.S. Food and Drug Administration lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law, according to a study released Monday.
The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients).
We Need Better Clinical Trials Our president explained to reporters why drugs have to be tested on all kinds of people to know who they work for and who can be harmed by them. Cancer patients deserve studies that include women and men, people under and over 65, and all major racial/ethnic groups. FDA […]
By Katie Thomas, The New York Times July 31, 2014 Johnson & Johnson, which has come under withering criticism for its response to problems with some of its medical devices, won cautious praise from critics on Thursday for its decision to withdraw three products used in uterine surgery because of a risk of spreading cancerous […]
By Peggy Orenstein New York Times July 26, 2014 BERKELEY, Calif. — ONE of the nastier aspects of breast cancer is that it doesn’t have the five-year sell-by date of some other malignancies: you’re not considered “cured” until you die of something else. Although it becomes less likely, the disease can come back eight, 10, […]