Modern Healthcare, October 8, 2014. “The thing that’s been missing from the model until now is the evidence,” said Diana Zuckerman, a researcher who has been critical of the Food and Drug Administration’s procedures for approving and monitoring medical devices.
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
Payment Reform Puts Medical-Device Industry On the Defensive
Modern Healthcare, October 7, 2014. Medical technology companies are warning that burgeoning pay-for-performance and risk-based reimbursement models will motivate providers to block access to clinically important innovations.
Read More »Medical Company May Be Falling Short Of Its Patient Safety Ideals
NPR, October 6, 2014. 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.
Read More »Not Enough Safety Testing On Medical Implant Devices, Studies Claim
CBS News, September 30, 2014. Every day, people receive medical implants — artificial valves, hip replacements, surgical mesh and the like — that may not have been rigorously tested before or after their approval by the U.S. Food and Drug Administration, two new studies contend.
Read More »Medical Devices Lack Safety Evidence, Study Finds
The Wall Street Journal, September 29, 2014. 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.
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