Earlier this week, Ireland temporarily suspended all procedures using transvaginal mesh devices to treat stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals, according to a government release from the country. Minister for Health Simon Harris announced the pause, saying that the Department Chief Medical Officer requested the pause in use […]
Renovia raises $25m
Women’s health company Renovia has raised $25.3 million in a new round of equity financing, according to a recently posted SEC filing. Renovia created and produces the Leva pelvic floor strengthening system designed to aid individuals suffering from pelvic floor disorders. The system contains sensor technology that allows the user to see the position of […]
Bayer loses bid to keep Essure cases in federal court
Bayer (ETR:BAYN), which last week said it’s taking its Essure female sterilization device off the U.S. market this year, lost a bid yesterday to keep a clutch of personal injury lawsuits in federal court. The German medical giant had a group of 16 cases that were originally filed in a Pennsylvania state court removed to the […]
FDA announces halt to U.S. Essure sales by Bayer
The FDA said today that Bayer (ETR:BAYN) will no longer sell or distribute its Essure permanent birth control device in the U.S., effective Dec. 31. FDA Commissioner Scott Gottlieb said the action follows a “series of earlier actions that the FDA took to address the reports of serious adverse events associated with its use,” according to an FDA […]
Establishment Labs prices $67m IPO
Breast implant maker Establishment Labs yesterday priced its initial public offering at $18 per share, saying it expects to gross nearly $67 million not including a possible underwriters option. Alajuela, Costa Rica-based Establishment Labs originally registered the offering at $58 million, saying it plans to use the proceeds to fund a pre-market approval study of its Motiva implants. The FDA […]
Dysis Medical raises $25m
Dysis Medical said yesterday it raised $25 million (GBP £18 million) in a new round to help support its Dysis colposcope used for cervical cancer screenings. The Dysis colposcope uses both optical imaging and software to scan the cervix to improve cervical cancer screening procedures, the company said. Funds in the round will help support […]
Endologix reports 1-year data from Ovation registry
Endologix (NSDQ:ELGX) this week touted 1-year results from its Lucy registry – a study that prospectively assessed endovascular aneurysm repair outcomes in women compared to men. The Irvine, Calif.-based company said that data from the study showed that at least 28% more women are eligible for minimally-invasive EVAR with Endologix’s Ovation abdominal stent graft system […]
Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding
Data from a collaboration between Ferring Pharmaceuticals, Merck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth. Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent the deadly condition. But […]
Boston Scientific wins third Mass. pelvic mesh trial
Boston Scientific (NYSE:BSX) last week won the third Massachusetts trial of a product liability lawsuit brought over two of its pelvic mesh products. Ana Martinez and her husband Jose sued Marlborough, Mass.-based Boston Scientific in August 2012 in the Bay State’s Middlesex County Superior Court. After a 16-day trial, the jury found June 15 that Boston was […]
Siemens Healthineers gets in on $5m round for ScreenPoint Medical
ScreenPoint Medical drummed up $5.0 million in a funding round led by the healthcare business at Siemens (NYSE:SI), saying it’s earmarked the proceeds for its Transpara mammography evaluation software. Siemens Healthineers was joined by private investors in the €4.3 million round, Nijmegen, Holland-based ScreenPoint said. The Transpara software uses deep learning and image databases to aid in evaluating mammograms. […]
On second try, TherapeuticsMD lands FDA nod for vaginal capsule
TherapeuticsMD (NSDQ:TXMD) said today that it won FDA approval for its applicator-free estradiol vaginal capsule, TX-004HR. The soft-gel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. Get the full story at our sister site, Drug Delivery Business News.
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