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 […]
FDA OKs Opus breast implant line from Sientra
The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]
Qiagen wins FDA nod for point-of-care PartoSure test
Qiagen (NYSE:QGEN) today touted the FDA’s approval of its PartoSure diagnostic test, designed to assess the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The non-invasive strip test detects placental alpha microglobulin-1 and can provide results in less than five minutes, according to Germany-based Qiagen. Get the full story at our sister […]
Nuvo launches pivotal trial for PregSense home maternity monitor
Pregnancy care device developer Nuvo Group said late last week it launched a trial of its PregSense maternal fetal monitoring system to compare it against cardiotocography, which is currently the standard of care. The Israel-based company’s PregSense device is a sensor-based wearable monitoring technology designed to measure markers of fetal and maternal wellbeing from metrics including […]
Boston Scientific acquires NVision Medical in $275m deal
Boston Scientific (NYSE:BSX) said today it inked a $275 million deal to acquire women’s health-focused NVision Medical, which produces an FDA-cleared device designed to collect cells from fallopian tubes as an early diagnosis of ovarian cancer. In the deal, Boston Scientific will pay $150 million up front with an additional $125 million in possible milestone payments […]
UPDATE: New Jersey jury hits BD subsidiary Bard with $68m pelvic mesh verdict
Updated to include a $35 million punitive damages verdict released today. Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard was reportedly hit yesterday with a $33 million verdict in a product liability lawsuit brought over its Avaulta and Align pelvic mesh products. A New Jersey jury in the Bergen County Superior Court awarded $23 million in compensatory […]
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