Bayer (ETR:BAYN) failed to tell FDA about thousands of injury complaints related to its Essure contraceptive device, according to newly unsealed lawsuit documents reported by Bloomberg. The lawsuit documents out of California claim that the underreporting went back before Bayer acquired Essure maker Conceptus for $1.1 billion in 2013. Bayer responded to Bloomberg last week that […]
Bayer
Essure study shows more pain, bleeding in women with implant
Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
7 ways the coronavirus is affecting medtech
Medtech companies face some tough times as the deadly coronavirus pandemic gains steam. But could this be the medical device industry’s Dunkirk, too? Just days ago, MassMEDIC president Brian Johnson made a call-out on LinkedIn for people to send ideas about how Massachusetts medical device companies could help fight COVID-19. He drew an analogy to […]
Bayer, Nuvisan to create drug discovery research unit in Berlin
Bayer (ETR:BAYN) announced that it entered into a definitive agreement to transfer some of its small molecule research unit to Nuvisan for an undisclosed amount. The agreement is slated to lay a foundation for Nuvisan to establish the Berlin-based research unit and support Bayer’s focus on the flexibility and productivity of its research & development operating model, according […]
Bayer and Exscientia partner to bring AI to drug discovery
Bayer (ETR:BAYN) announced that it is entering into a collaboration agreement with artificial intelligence drug discovery company Exscientia to identify and optimize novel lead structures for potential drug candidates in treating cardiovascular and oncological diseases. The agreement, announced earlier this month, is slated to see the companies work together on early research projects combining Exscientia’s proprietary […]
Bayer wins N.J. Essure case on appeal
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
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 having been injured by a medical device, women made up 67%, compared with men […]
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 […]