Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery alerted U.K. regulators after discovering counterfeit LigaClip surgical clips on the U.S. market that may have also been distributed to U.K. hospitals.
Ethicon
J&J says unsealed FDA letters on vaginal mesh sales taken “out of context”
New details on Johnson & Johnson’s (NYSE:JNJ) marketing of its controversial transvaginal mesh implants are again in the spotlight as unsealed documents suggest that the healthcare giant sold the devices for an additional 9 months after the FDA deemed the products adulterated and asked J&J to pull them off the shelves.
MassDevice.com +7 | The top 7 med-tech stories for the week of June 11, 2012
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
MassDevice.com +3 | The top 3 med-tech stories for June 13, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Ethicon warns on counterfeit surgical clips on the U.S. market
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery warned healthcare providers this week that it discovered counterfeit LigaClip surgical devices in distribution in the U.S.
Weight loss: FDA panel wants a higher bar for medical devices aimed at curbing obesity
High-risk medical devices intended to help obese patients lose weight should result in more weight loss than lower-risk methods, an FDA advisory panel said last week
"For a 1-and-done [a permanently implanted device], or a device equivalent to a gastric bypass, you should have higher expectations of the weight loss," said panelist Dr. Steven Schwaitzburg, of Harvard Medical School. "Whereas, if we have lower-risk devices and are able to establish other types of endpoints like bridge [to surgery], exercise, etc., then [a lower bar for excess weight loss would be acceptable]."
FDA clears Ethicon’s 1st surgical set docs can assemble inside the body | Regulatory Roundup
Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery.
FDA clears Ethicon’s 1st surgical set docs can assemble inside the body
Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery.
Transvaginal mesh suits filed against J&J in Canada | Legal News
The legal lollapalooza over transvaginal mesh implants has spilled over north of the border, where a class action lawsuit against Johnson & Johnson (NYSE:JNJ) was filed accusing the health care giant of failing to adequately warn of the devices’ risks.
Weight loss study: Bariatric surgery may treat Type 2 diabetes better than medicine
Gastric bypass and sleeve gastrectomy devices may be more effective in treating Type II diabetes than medication, according to a new study released at the annual meeting of the American College of Cardiology in Chicago today.
J&J responds on vaginal mesh controversy
Health care giant Johnson & Johnson (NYSE:JNJ) insists it followed appropriate regulatory guidance with its Gynecare Prolift transvaginal mesh product in the U.S. during the 3 years before obtaining FDA clearance.