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 […]
FDA ramps up scrutiny of materials in medical devices
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 […]
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