The movie Frankenstein inspired eight-year-old Earl Bakken to consider how electricity could restore life and health to the human body. Bakken went on to invent the first external cardiac pacemaker and to co-found medtech giant Medtronic in 1949. Bakken’s fascination with the effects of electricity on the human body continued throughout his career, and he amassed a collection of […]
Johnson & Johnson agrees to $117m pelvic mesh settlement with 41 states, DC
Johnson & Johnson (NYSE:JNJ) yesterday agreed to pay $117 million to settle charges of deceptive marketing of its pelvic mesh products with 41 states and the District of Columbia. The states and DC alleged that J&J and subsidiary Ethicon broke state consumer protection laws by misrepresenting the safety and effectiveness of its mesh devices, which […]
Australia suspends sales of certain textured breast implants
Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma. The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases […]
Meditrina raises $13m to commercialize Aveta device
Meditrina said yesterday that it completed a round of equity financing worth $13 million for the commercialization of its Aveta System for treating intrauterine pathologies. The San Jose, Calif.-based company’s Aveta system won FDA 510(k) clearance in May; the company plans to put the $13 million toward the platform’s market launch. The Aveta system is […]
FemSelect closes enrollment for mesh-free pelvic floor device study
FemSelect yesterday said it closed enrollment in the EnPlace post-market study of its mesh-free pelvic floor repair device. The Tel Aviv, Israel-based company enrolled 60 female patients aged 36 to 84 years at 15 sites in the U.S., Germany and Israel for the global, two-phase study. The observational study will assess the long-term safety, durability […]
CDRH proposes women’s health plan
The FDA has released a new proposed plan to improve medical device safety for women. The agency’s Center for Devices and Radiological Health (CDRH) said today that the proposed strategic plan will address sex- and gender-specific issues in medtech design, development, clinical trial design and other medical device-related matters. The strategic plan is part of […]
West Virginia AG sues Johnson & Johnson over pelvic mesh
West Virginia attorney general Patrick Morrisey yesterday became the latest state AG to sue Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon over its pelvic mesh products. The newest complaint, filed Sept. 18 in the Monongalia County Circuit Court, alleges that Ethicon’s “unlawful, unfair and deceptive marketing of polypropylene mesh products” concealed the potential risks of pelvic […]
Apple announces medical studies using new Research app
Apple (NSDQ:AAPL) said yesterday that it is launching medical studies into women’s health, hearing, and heart function and movement with its new Research app. The Cupertino, Calif.-based company said the app will show how medical research is conducted and allow participants to contribute to potential medical discoveries. The Research app will be available as a free […]
INVO Bioscience prices $13m offering
INVO Bioscience (OTCQB:IVOB) yesterday registered a common stock offering of more than $13 million, according to a regulatory filing. The Lakewood Ranch, Fla.-based company is putting up nearly 41 million shares of its common stock for close to $13.1 million. There are currently nearly 39 million outstanding shares, according to the filing. They are traded […]
FDA approves Axonics sacral neuromod for FI
Axonics Modulation Technologies (NSDQ:AXNX) today said it received FDA approval for its rechargeable sacral neuromodulation device. The rechargeable SNM device is designed to treat urinary and bowel dysfunction in adults and features a neurostimulator about the size of a USB drive that lasts 15 years in the body. Irvine, Calif.-based Axonics also has a pre-market approval […]
Allergan sued over textured breast implants
Two women have filed a class-action lawsuit against Allergan (NYSE:AGN), alleging that the company’s textured breast implants gave them a rare form of cancer. Separately, a California judge dismissed two lawsuits against Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide over injuries allegedly caused by Mentor’s silicone breast implants. In the suit against Allergan, a woman […]
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