Jeremy Hunt, the U.K.’s health & social care secretary, this week ordered a National Health System safety audit of the use of plastic mesh implants to treat vaginal prolapse and female urinary incontinence. Hunt said the review of vaginal mesh and two other products – the Primodos hormone-based pregnancy test and the anti-epilepsy drugsodium valproate […]
PharmaJet, Genexine ink deal for needle-free vaccine development
PharmaJet said today it inked a global license agreement with South Korean bioptherapeutics company Genexine to develop and commercialize DNA vaccines using PharmaJet’s needle-free injection system. Through the deal, Genexine will gain access to use both the PharmaJet Stratis and Tropis devices for their Phase I and Phase IIa human clinical studies. The deal also […]
Acessa Health touts Medicaid win
Acessa Health said today that 32 state Medicaid programs now provide access to the company’s Acessa procedure designed to treat uterine fibroids using radiofrequency ablation. The Acessa procedure, utilizing the Acessa system, is designed as a uterine sparing alternative to hysterectomy. The procedure can treat most sizes and locations of fibroids, including those in the uterine […]
Appeals court upholds $19m Boston Scientific loss in pelvic mesh case
Boston Scientific (NYSE:BSX) has lost another bid as it looked to overturn an $18.5 million loss in a product liability suit over alleged injuries caused by its Obtryx pelvic mesh. A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based […]
Teva closes $703m sale of global women’s health biz to CVC Capital
Teva Pharmaceuticals (NYSE:TEVA) has finished the $703 million sale of a portfolio of products in its global women’s health business to CVC Capital Partners. The portfolio of divested products includes fertility medicines like Ovaleap, oral contraceptives like Zoely and osteoporosis drugs like Actonel. Now that the sale is closed, the portfolio of medicines will be sold under […]
New Zealand’s Medsafe regulatory body removes pelvic mesh products from market
New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today. The agency said the product’s removal was the outcome of a recent regulatory action on surgical mesh products, specifically those designed for treating pelvic organ prolapse via transvaginal implantation and […]
CDC group tackles access to birth control for women in Puerto Rico
Between May 2016 and August last year, a group organized by the CDC provided services to more than 21,000 women in Puerto Rico in an attempt to boost access to contraception, lower the rate of unintended pregnancy and lessen the number of Zika-related birth defects on the island. You can read more about women’s health […]
Hologic launches $1B debt offering
Hologic (NSDQ:HOLX) plans to launch a $1 billion private offering made up of 4.375% senior notes due 2025 and new senior notes due 2028. The company reported that it plans to use its available cash, the offering’s proceeds and funds from a revolving credit facility to redeem $1 billion of outstanding 5.25% senior notes due in […]
Hologic wins CE Mark for Brevera breast biopsy system
Hologic (NSDQ:HOLX) said yesterday that its Brevera breast biopsy system with CorLumina imaging tech won CE Mark clearance in the E.U. The real-time breast biopsy and verification system is designed to boost accuracy and improve the patient experience by streamlining the biopsy process, according to Hologic. The technology combines tissue acquisition, real-time imaging, sample verification and […]
Gynesonics touts pivotal IDE Sonata trial results
Gynesonics today released results from the pivotal FDA investigational device exemption cleared trial for its Sonata system designed for the incision-free treatment of uterine fibroids, touting a 99% freedom from surgical reintervention for heavy menstrual bleeding. The Redwood City, Calif.-based company’s Sonata trial is a prospective, longitudinal, multi-center trial exploring the safety and effectiveness of […]
Planmed Oy wins FDA nod for Clarity 2D digital mammography system
Planmed Oy said yesterday it won FDA approval for its Planmed Clarity 2D full-field digital mammography system. The company said the Clarity 2D system is designed to provide improved image quality, optimal ergonomics and usability for breast cancer screenings. The system also supports diagnostic work-up examinations and biopsy procedures, Planmed said. “We are excited that […]
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