Mirabilis Medica said today it won CE Mark approval in the European Union and FDA investigational device exemption for its Mirabilis System designed to treat uterine fibroids. The Bothell, Wash.-based company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said. The device […]
Women's Health
FDA warns on lymphoma risk associated with breast implants
The FDA this month warned of an association between breast implants and the development anapestic large cell lymphoma. The federal watchdog warned that the rare T-cell lymphoma can develop following implants, based on data the agency, and other health and regulatory bodies worldwide, have been collecting since 2011. The exact number of cases “remains difficult […]
Viveve prices $30m offering
Viveve (NSDQ:VIVE) late last week priced an upcoming offering, looking to raise $30 million to support its Viveve system. The Sunnyvale, Calif.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. Viveve said it plans to offer approximately 7.5 million shares of stock at $4 per share, with a 30-day underwriter’s […]
GE Healthcare buys fetal monitor maker Monica Healthcare
GE Healthcare (NYSE:GE) said today that it paid an unspecified amount for U.K.-based Monica Healthcare. Nottingham-based Monica Healthcare makes a line of wearable, wireless fetal monitors that were used with 100,000 patients last year, GE Healthcare said. Starting in 2015, the Wauwatosa, Wis.-based health giant was the North American distributor for Monica’s Novii wireless patch, a […]
This uterine fibroid treatment is underused despite being cost-effective
A new study suggests that a minimally invasive, image-guided treatment for uterine fibroids is used a lot less than other surgical treatments. Hysterectomies were performed 65 times more than the minimally invasive uterine fibroid embolization (UFE), which has even been proven to cost less and result in a shorter hospital stay. “These findings suggest there […]
Glenmark, Evestra ink deal to develop generic NuvaRing
Glenmark Pharmaceuticals and Evestra said today that the companies inked a development, license and commercialization deal for a generic version of Merck’s NuvaRing. Development of the etonogestrel/ethinyl estradiol contraceptive is under way, according to the companies, and they plan to file an Abbreviated New Drug Application in fiscal 2019. Get the full story at our sister […]
Viveve Medical reports success treating vaginal laxity
Viveve Medical recently published the results of a clinical study of its Viveve I treatment in the Journal of Sexual Medicine, showing that women who received the treatment reported being more likely to have no vaginal laxity. The Viveve Treatment of the Vaginal Introitus to Evaluate Efficacy study is one of the first studies to study […]
Actamax seeks FDA nod for sprayable adhesion barrier trial
Actamax Surgical Materials, a DSM-DuPont joint venture, said today that it submitted an Investigational Device Exemption application to the FDA for its adhesion barrier device in gynecological laparoscopic surgery. Adhesions, excessive scar tissue that can form between adjacent internal tissues, are a result of normal wound healing. Adhesions occur post-surgical operations at rates of 50-90%. […]
Hologic to buy Cynosure in $1.65B deal
Hologic (NSDQ:HOLX) said today that it landed a deal to acquire Cynosure Inc. (NSDQ:CYNO) and its portfolio of medical aesthetics products for $1.65 billion. Marlborough, Mass.-based Hologic offered $66 per share – a 28% premium compared to Cynosure’s close yesterday. The transaction, which has a reported enterprise value of $1.44 billion, comes 1 day after Allergan […]
TransEnterix touts French debut for Senhance robot-assisted surgery device
TransEnterix (NYSE:TRXC) yesterday touted the 1st clinical use in France of its Senhance robot-assisted surgery platform. The 1st French case, performed by Dr. Celine Chauleur of CHU Saint-Ètienne, was a hysterectomy to treat endometrial cancer with pelvic lymphadenectomy Feb. 7. The patient was discharged less than 24 hours after surgery, Morrisville, N.C.-based TransEnterix said. “I am very pleased […]
Urinary device startup Vesiflo raises $2.4m, looks to bring in $7m
Medical device startup Vesiflo raised $2.4 million in a new round of equity financing to support its iFlow device designed to treat women with impaired detrusor contractility. Funds raised came from 26 unnamed investors, and the company is looking to raise an additional $4.6 million to bring the round to a total of $7 million […]