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 […]
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 […]
Confer Health raises $9.5m for fertility diagnostic
Confer Health said today that it raised $9.5 million to support its development of affordable, at-home diagnostic devices featuring interchangeable cartridges, a reusable analyzer and a mobile app. The Boston, Mass.-based company’s first urine-based diagnostic test is designed to help couples conceive by tracking three fertility hormones. Get the full story at our sister site, Drug Delivery […]
TherapeuticsMD negotiates label for vaginal capsule after NDA resubmission
TherapeuticsMD (NSDQ:TXMD) is negotiating with the FDA over the proposed label for its investigational, applicator-free estradiol vaginal capsule, TX-004HR, the company reported today. The softgel 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 […]
UPDATE: FDA restricts sales of Bayer’s Essure female sterilization device
Updated to include commentary from Bayer The FDA today slapped restrictions on the U.S. sale of the Essure female sterilization device made by Bayer (ETR:BAYN), after concluding that some patients were not adequately warned of its risks. The controversy around Essure, a small metal coil that’s placed in the fallopian tubes via catheter, has grown in recent years […]
Siemens Healthineers wins FDA nod for Mammomat mammography system
Siemens (NYSE:SI) Healthineers business said this week it won FDA approval for its Mammomat Revelation mammography system. The newly cleared mammography system includes the company’s InSpect integrated specimen imaging tool and a new HD breast biopsy solution that allows for one-click targeting of suspicious areas, Siemens said. The integrated InSpect tool enables imaging and real-time review of […]
Laborie Medical to pay $214m for Cogentix
Laborie Medical Technologies said today that it agreed to pay $214 million for Cogentix Medical (NSDQ:CGNT) and its line of urology and gynecology devices. Formed by the 2015 merger of Vision-Sciences and Uroplasty, Minnetonka, Minn.-based Cogentix makes the Urgent PC neuromodulation device for treating overactive bladder syndrome, the PrsimeSight cystoscopy and EndoSheath devices and Macroplastique, an injectable soft-tissue bulking agent for […]
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