The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts […]
Sen. Warner enlists healthcare industry help on cybersecurity
U.S. Senator Mark Warner (D-Va.) wrote a letter to several healthcare organizations yesterday, asking their help in improving cybersecurity in the industry. A member of the Senate Finance Committee and chair of the Senate cybersecurity caucus, Warner pointed to apparent gaps in oversight, expressed concern about the impact of cyberattacks on the health care sector, […]
Analyst downgrades pressure medtech stocks
Several medical device companies took hits yesterday after analysts on Wall Street downgraded their stocks, on a day when the major market indices each closed up a hair, and even medtech firms that enjoyed upgrades came under pressure. Globus Medical (NYSE:GMED) suffered the most after Morgan Stanley analyst David Lewis cut his rating on the stock from […]
UPDATE: FDA updates on post-market study revisions, oversight for Bayer’s Essure
Updated to include response from Bayer. The FDA today released steps it is taking to maintain its oversight of Bayer‘s (ETR:BAYN) Essure permanent birth control device following its removal from the U.S. market this summer, including extensions and revisions to a required post-market study of the device. In an official posting, FDA Commissioner Dr. Scott […]
Gerresheimer taps Metzner as CFO | Personnel Moves – December 14, 2018
Gerresheimer said late last month that it tapped Dr. Bernd Metzner as its new chief financial officer, set to take position at the latest by July 1 next year. Prior to joining the Dusseldorf-based company, Metzner acted as CFO at Ströer, a position he took up in June 2014. He also held positions at Bayer […]
FDA grants breakthrough status to joint Merck-Bayer AI program
Merck and Bayer have been granted FDA Breakthrough Device Designation for the collaborative Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence Pattern Recognition software. CTEPH can be difficult to diagnose because its symptoms are similar to asthma and chronic obstructive pulmonary disease symptoms. CTEPH affects five people per million annually worldwide. Computed tomography pulmonary angiography and […]
Report: Women in Australia to pursue class action over Bayer’s Essure
A group of women in Australia will be joining other women worldwide in pursuing a class action lawsuit against Bayer (ETR:BAYN) for medical problems allegedly associated with its Essure permanent birth control device, according to a report from The Guardian. The suit, which will be led by law firm Slater and Gordon, joins similar suits against […]
Bayer fires back against Essure safety claims
Bayer (ETR:BAYN) last week fired back against claims that its Essure permanent birth control device is less than safe and effective after having announced plans to pull the device from the shelves in the US a week earlier. Last Thursday, the pharmaceutical giant published a press release lauding the device as the only FDA-approved non-incisional form […]
Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial […]
Bayer loses bid to keep Essure cases in federal court
Bayer (ETR:BAYN), which last week said it’s taking its Essure female sterilization device off the U.S. market this year, lost a bid yesterday to keep a clutch of personal injury lawsuits in federal court. The German medical giant had a group of 16 cases that were originally filed in a Pennsylvania state court removed to the […]
FDA announces halt to U.S. Essure sales by Bayer
The FDA said today that Bayer (ETR:BAYN) will no longer sell or distribute its Essure permanent birth control device in the U.S., effective Dec. 31. FDA Commissioner Scott Gottlieb said the action follows a “series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use,” according to an FDA […]
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