Becton Dickinson (NYSE:BDX) will pay $60 million to 48 U.S. states to resolve allegations that its C.R. Bard business deceptively marketed transvaginal surgical mesh devices, state attorneys general in California and Washington announced today. Mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs, but they instead sparked […]
Viveve gains stress urinary incontinence tech patent
Viveve Medical (NSDQ:VIVE) announced that the U.S. Patent & Trademark Office issued a patent for its stress urinary incontinence technology. USPTO issued U.S. Patent No. 10,779,874, allowing Viveve to expand its intellectual property portfolio ahead of its U.S. pivotal Pursuit clinical trial evaluating its treatment of SUI in women, according to a news release. Englewood, Colo.-based […]
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced today that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. amid the COVID-19 pandemic. UroShield […]
Vessi Medical raises $1.7m for cryoablation therapy
Vessi Medical announced today that it raised $1.7 million in funding for its cryoablation treatment for superficial bladder cancer. Agriline, the Trendlines Group, the Israel Innovation Authority and ExitValley investors all participated in the financing round to support the minimally invasive treatment, according to a news release. Misgav, Israel-based Vessi Medical touts its cryoablation solution, […]
DTW Podcast: Truist’s Kaila Krum says Medtronic prepping for growth
In an interview with DeviceTalks Weekly Podcast, Truist Securities managing director Kaila Krum says Medtronic executives are retooling the company to keep pace with smaller, more focused competitors. Breaking down the company’s Q1 call, Krum says Medtronic is seen as a company that’s too big to grow market share quickly. On the call, new CEO […]
Hologic buys Accessa Health for $80M
Hologic (NSDQ:HOLX) announced that it acquired fibroid treatment developer Acessa Health in a deal worth approximately $80 million. Austin, Texas-based Acessa markets the Acessa ProVu fully integrated laparoscopic system for combining radiofrequency ablation with intra-abdominal ultrasound visualization and guidance mapping for treating women with symptomatic, benign uterine fibroids. Marlborough, Mass.-based Hologic said in a news release […]
FDA clears Pelvital pelvic floor device
Pelvital announced that it received FDA clearance for its Flyte device for treating those with stress urinary incontinence. Minneapolis-based Pelvital touts Flyte as a first-of-its-kind, non-invasive, intravaginal home-use device designed to strengthen the pelvic floor muscles, which can help women with stress urinary incontinence, according to a news release. Physicians at the Arctic University of […]
FDA: Thousands of new breast-implant-related illnesses reported
The FDA today reported that it has received nearly 2,500 new reports globally of “breast implant illness” or BII. Reports of new breast implant-related cancer were also up. BII is not cancer, nor is it a term often found in medical literature, the agency said. But it is frequently used by patients and healthcare providers […]
BREAKING: Bayer settles 90% of Essure claims for $1.6B
Bayer (ETR:BAYN) announced today that settled approximately 90% of U.S. claims involving women alleging injuries related to its Essure device. Leverkusen, Germany-based Bayer reached agreements with plaintiff law firms on about 90% of the nearly 39,000 filed and unfiled U.S. Essure claims from women who allege device-related injuries, according to a news release. Settlements include all […]
Bayer sets aside nearly $1.4B for potential Essure settlements
Bayer (ETR:BAYN) during its second quarter ended June 30 set aside €1.245 billion ($1.39 billion), mainly to provide for potential lawsuit settlements related to its Essure permanent birth control device. Some of the provision was also for litigation defense costs and other pharmaceutical matters. As of July 24, Bayer faced U.S. lawsuits from roughly 32,000 Essure […]
FDA approves new Medtronic neurostim leads
Medtronic (NYSE:MDT) announced today that it received FDA approval for its InterStim Micro neurostimulator and SureScan MRI leads. Fridley, Minn.-based Medtronic’s InterStim Micro device for delivering sacral neuromodulation (SNM) therapy is used in treating overactive bladder, fecal incontinence and non-obstructive urinary retention. According to a news release, it is the smallest rechargeable device of its kind. […]
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