A New Jersey appeals court has thrown out a woman’s product liability lawsuit against Bayer (ETR:BAYN) over its Essure permanent birth control device. Arcelia Sandobal Gomez had the Essure metal coils implanted in her fallopian tubes in 2014 and claimed she suffered intermittent and severe abdominal pain and chronic and abnormal vaginal bleeding afterwards. Gomez […]
Bayer loses Essure appeal in Indiana
An Indiana appeals court has ruled that more than 30 women suing Bayer (ETR:BAYN) over its Essure permanent birth control device may proceed with their case. The women claimed that after they had Essure implanted in their fallopian tubes, they suffered a number of health problems, including “menorrhagia, extreme fatigue, abdominal pain, back pain, joint […]
Bayer wins FDA clearance for expanded CT injection system
Bayer received FDA 510(k) clearance for expanded use of its Medrad Stellant Flex CT injection system with Certegra Workstation. The system is cleared for use in contrast-enhanced mammography (CEM), which can allow for better visualization fo abnormalities in breast tissue that may not be visible in standard mammography. “This FDA clearance underscores Bayer’s continued commitment […]
Report: More women harmed by medical devices than men
This article has been updated with comments from the FDA and from Madris Tomes. A new investigation of FDA adverse event data has revealed that more women are harmed by medical devices than men. The report published by the International Consortium of Investigative Journalists (ICIJ) shows that among 340,000 people whom the FDA listed as […]
FDA panel wants info on metal implant reactions
This article has been updated with a link to the FDA webcasts of the proceedings. An FDA panel will meet this week to discuss immunological responses to medical device implants made of metal, including artificial hips and the Essure permanent birth control device. The Immunology Devices Panel of the agency’s Center for Devices and Radiological […]
Medtech trade lobbies unite for anti-tax push
A group of medical device industry trade associations are joining together to push the U.S. Congress toward repealing the medical device tax that’s been in abeyance since 2015. MDMA, AdvaMed, MITA and a group of medical innovators, physician inventors, patient groups and more today sent a letter urging congressional leadership to permanently repeal the medical […]
Bayer leads One Drop’s $40m Series B, inks deal to expand past diabetes
Bayer (ETR:BAYN) led a $40 million Series B round for glucose monitor maker One Drop, licensed its platform for treating conditions beyond diabetes and put its pharma president on the One Drop board. New York City-based One Drop developed a compact blood glucose monitor, pairing it with an app designed to provide behavioral cues and one-on-one coaching. […]
Bayer launches contrast agent injector
Bayer (ETR:BAYN) yesterday said that it has launched its Medrad Stellant Flex CT injection system. Stellant Flex is a user-driven system that requires minimal technologist training and automation, according to Whippany, N.J.-based Bayer U.S. It offers individualized patient protocols and personalized imaging with flexible options for capital equipment through the company’s TechCare program. “For more than […]
FDA updates on Essure device report numbers, post-market study data
The FDA yesterday provided an update on its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device, which was removed from the U.S. market last summer. The federal watchdog said that it received approximately 6,000 medical device reports last year, a decrease from the nearly 12,000 it received in 2017 but close to the numbers […]
The grim stories behind seven of medtech’s worst failures
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]
Bayer loses bid to toss some claims in Essure class action suit
A federal judge in Philadelphia will allow six women who are suing Bayer (ETR:BAYN) over its Essure sterilization implant to proceed with their personal injury claims and three others to pursue their breach-of-warranty claims. One woman who became pregnant following implantation with Essure will be able to pursue her claim that Bayer fraudulently concealed the […]
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