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.
Fertility wearable dev Ava raises $30m in Series B
Reproductive-focused patient monitoring developer Ava said today it raised $30 million in a Series B round of funding to support its cycle-tracking sensor bracelet. The majority of the financing in the round came from existing investors, the Switzerland-based company said, and was joined by European VC firm Btov and SVC Ltd. The company’s flagship device […]
UPDATE: 60 Minutes report claims unapproved plastic sources used in Boston Scientific pelvic meshes
Updated to include Boston Scientific’s response to the news piece. Boston Scientific (NYSE:BSX) stocks fell slightly in pre-market trading after being covered in a 60 Minutes episode focused on gynecological pelvic mesh implants which are the source of a massive multi-district litigation, including claims that the company knowingly purchased inauthentic Chinese plastic materials for production. The […]
60 Minutes to speak to Boston Scientific in coverage of pelvic mesh MDL
CBS’s 60 Minutes will speak to Boston Scientific (NYSE:BSX) this week as the news program covers the massive multi-district litigation over gynecological pelvic mesh implants. The program referred to the multi-district litigation over the implants as the largest such litigation since asbestos, according to a press release. In early 2016, the FDA reclassified surgical meshes to […]
Minerva Surgical seeks retraction of Hologic-backed NovaSure study
Minerva Surgical is seeking the retraction of a study backed by rival Hologic (NSDQ:HOLX) comparing its NovaSure endometrial ablation system to Minerva’s competing device, alleging “material misleading statements” that violate ethics guidelines. Results from the 189-patient study, published in the International Journal of Women’s Health, found a higher one-year rate of amenorrhea and higher quality of life for women […]
Allergan touts 5-year data for Liletta intrauterine contraceptive
Allergan (NYSE:AGN) and its nonprofit partner, Medicines360, touted five-year data today from an on-going pivotal trial of its intrauterine device, Liletta. The levonorgestrel-releasing contraceptive is approved in the U.S. to be used to prevent pregnancy for up to four years. Get the full story at our sister site, Drug Delivery Business News.
Hologic wins FDA PMA for ThinPrep automated Pap test imager
Hologic (NSDQ:HOLX) said today it won FDA premarket approval for its ThinPrep integrated imager designed for the automated imaging of Pap tests. The Marlborough, Mass.-based company’s ThinPrep imager is designed to aid cytology technicians in identifying abnormal cells, and combines an imaging station and review scope into a single unit. The system takes approximately 90 seconds […]
Laborie Medical closes $214m Cogentix buy
Laborie Medical Technologies said today that it closed the $214 million acquisition of Cogentix Medical (NSDQ:CGNT). With about 85% of the urology and gynecology device maker’s shares tendered over the weekend, meeting the minimum tender requirement, the stage was set for the deal to close today. The $3.85-per-share cash tender pulled in some 51.5 million shares, for about $198.2 million, […]
Hologic touts study comparing NovaSure to Minerva’s endometrial ablation device
Hologic (NSDQ:HOLX) yesterday released results from a study comparing its NovaSure endometrial ablation system to Minerva Surgical‘s endometrial ablation device, touting a higher one-year rate of amenorrhea and higher quality of life for women treated with the NovaSure, despite experiencing a higher rate of perioperative adverse events. Results from the trial were published in the International […]
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