INVO Bioscience (OTCQB:IVOB) said last week that it received CE Mark approval for its InvoCell culture and retention device as an alternative to traditional in vitro fertilization treatment. InvoCell won FDA de novo approval in November 2015 and was launched in the U.S. in April 2016. Currently, it is distributed throughout the U.S. under an $8 […]
FDA approves expanded indication for Liletta 6-year IUD
Medicines360 and its partner Allergan (NYSE:AGN) said today that the FDA approved Medicines360’s supplemental new drug application to extend the duration use of the Liletta intrauterine device for up to six years. The Liletta levonorgestrel-releasing intrauterine system now has the longest approved duration of use for a hormonal intrauterine device in the U.S., according to a […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]
Report: Imaging industry put $9m into pushing 3D mammograms despite lack of evidence
Companies that make 3D mammography equipment have spent millions on marketing the devices, even though scientific evidence of their superiority to traditional mammography is lacking, according to a new report. The report by Kaiser Health News says that Hologic (NSDQ:HOLX), GE Healthcare (NYSE:GE), Siemens Healthineers and Fujifilm (TSE:4901) have paid doctors and teaching hospitals a collective $9.2 […]
FDA updates recommendations on breast implants
The FDA today issued a draft guidance to propose labeling recommendations to manufacturers of breast implants to ensure women have access to complete information about their benefits and risks. The recommendations include a boxed warning, a patient decision checklist in the device’s labeling, updated recommendations for patient screening for device rupture and more, according to […]
9 early medical devices that will horrify or amaze you
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 […]
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