Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed […]
Women's Health
Allergan wins FDA nod for Natrelle Inspira SoftTouch breast implant
Allergan (NYSE:AGN) said today it won FDA approval for its Natrelle Inspira SoftTouch breast implants designed for breast reconstruction, augmentation or revision surgeries. The newly cleared Inspira SoftTouch implant is designed from a new medium firmness gel, the company said, bringing the total number of firmness options or its Natrelle line up to 3. “I am excited […]
Femasys raises $40m Series C for FemBloc permanent female contraception device
Femasys said earlier this month that it closed on a Series C round worth $40 million it plans to use on a pivotal trial of its FemBloc permanent female contraception device now that it has FDA approval for the study. Atlanta-based Femasys said the round was arranged and led by Los Angeles-based investment bank Salem Partners, with […]
Minerva Surgical raises $16.7m for Aurora endometrial ablation device
Minerva Surgical reported a funding round worth $16.7 million and said it wants to raise $10 million more. Redwood City, Calif.-based Minerva, founded in 2008, is developing technologies for treatment of abnormal uterine bleeding. Its flagship device is the Aurora endometrial ablation system, which targets and eliminates the endometrial hyperplasia in a procedure that takes as little […]
iCad deals VersaVue software, DynaCAD to Philips InVivo unit for $3.2m
iCad (NSDQ:ICAD) said yesterday that it agreed to deal its VersaVue software and DynaCAD breast and prostate imaging devices to Royal Philips‘ (NYSE:PHG) InVivo unit for $3.2 million. Nashua, N.H.-based iCad said the Dec. 16 deal includes a holdback reserve of $350,000. The deal is expected to close by Jan. 31, 2017; if it doesn’t close by […]
AirXpanders wins de novo FDA clearance for AeroForm breast tissue expander
AirXpanders (ASX:AXP) said yesterday it won FDA de novo clearance for its AeroForm tissue expander system designed for breast reconstruction procedures, and announced it is preparing to launch the device in the U.S. The Palo Alto, Calif.-based company’s AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and […]
Halt Medical touts BCBS reimbursement win in South Carolina
Halt Medical said today that it won coverage from Blue Cross Blue Shield of South Carolina for procedures using its Acessa System to remove fibroids. Acessa uses radiofrequency ablation guided by ultrasound to remove fibroids, which are benign, non-cancerous tumors that occur in women’s uteri, often during childbearing years, Halt Medical said. The Brentwood, Calif.-based company […]
Seno Medical touts Imagio analsyses data, looks to 2017 for PMA bid
Seno Medical Instruments today released data from 2 new analyses of a post-market study of its Imagio opto-acoustic technology designed to aid in the diagnosis of breast cancer, hoping to submit a Premarket Approval application to the FDA early next year. The Imagio system combines traditional ultrasound with light-based imaging, providing physicians with a closer look […]
French women file complaints over complications with Bayer’s Essure
Two French women who’ve used Bayer‘s (ETR:BAYN) controversial Essure contraceptive implant have filed a legal complaint alleging similar side-effects to those filed in the U.S. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said last year that in the 13 years since Essure’s approval, the agency had received 5,093 complaints, […]
Researchers show drug, catheter combo speeds up labor delivery
Using the drug misoprostol in combination with a Foley balloon catheter to induce labor can lead to a speedier delivery, with women delivering several hours earlier than either method alone, according to research from the University of Pennsylvania. The team’s work was published in Obstetrics & Gynecology. Nearly 1 million women who deliver in the U.S. […]
Immunovaccine’s targeted ovarian cancer therapy wins orphan drug status in EU
Immunovaccine Inc. said today that the European Medicines Agency granted orphan drug designation for its immunotherapy candidate for ovarian cancer in the E.U. Orphan drug designation is granted to medicines intended for disease with a prevalence no greater than 5 in 10,000 people. According to the Nova Scotia-based company, ovarian cancer affects 3 per 10,000 […]