Endo International (NSDQ:ENDP) last week settled another batch of product liability lawsuits brought against subsidiary American Medical Systems Holdings over its pelvic mesh implants. Last October the company agreed to put some 20,000 of the lawsuits to rest, saying it would increase the amount of money it had set aside to cover the claims from $1.2 billion to […]
Women's Health
iCad launches iReveal breast density software
iCad (NSDQ:ICAD) said Monday it launched its iReveal breast density software designed to deliver reproducible breast density assessments. The module was designed to be used with the company’s PowerLook advanced mammography platform. The software will help treat an estimated 40% of women in the U.S. who have dense breast tissue that can mask the presence of […]
Halt Medical wins reimbursement for Acessa fibroid treatment
Halt Medical said yesterday that its Acessa treatment for symptomatic firbroids is now covered by Blue Cross Blue Shield of Michigan. 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. “Millions of women suffer from heavy bleeding, pain […]
Biotronik launches CRT in women study
Biotronik said last week it enrolled the 1st patient in its Biowomen study investigating the difference in cardiac resynchronization therapy response in men and women to understand if women respond better to the treatment. The trial seeks to enroll 247 patients of each gender over 2 years, with a 1-year follow-up and results expected in 2018, the […]
FDA OKs TVU as 2nd placement test for Bayer’s Essure
(Reuters) — Bayer (ETR:BAYN) said today that the FDA approved using transvaginal ultrasound as an alternate test to confirm if the company’s Essure permanent birth control device has been placed properly. Essure is a small metal coil inserted into woman’s fallopian tubes. Since its FDA approval in 2002, women using the device have sent the safety watchdog more than […]
Caldera Medical wins FDA 510(k) for next-gen Vertessa Lite mesh
Caldera Medical said today it won FDA 510(k) clearance for its next-generation Vertessa Lite polypropylene mesh for treating pelvic organ prolapse. The new version of the mesh is lighter, 31% stronger than other market-leading meshes and has a 32% increased suture pull out strength, the Agoura Hills, Calif.-based company said. “As part of our continuous […]
GC Aesthetics plans $75m IPO
Breast implant maker GC Aesthetics unveiled plans yesterday for a $75 million initial public offering. The company said it plans to spend $11.5 million on sales and marketing in new and existing countries, including the launch of its Impleo implant, $4.2 million to grow its product portfolio and $5 million to expand manufacturing. The net proceeds will […]
FDA panel to discuss safety of Bayer’s contraceptive device Essure
(Reuters) — The U.S. Food and Drug Administration said it would discuss the safety and effectiveness of Bayer (ETR:BAYN) AG’s controversial contraceptive device, Essure, in a public panel meeting after receiving more than 5000 complaints, including those of deaths and pregnancies. Essure, which is the only approved permanent birth control device in the United States, is […]
AirXpanders raises $28.3m in Aussie IPO
Breast tissue expansion device maker AirXpanders said yesterday that it raised $28.3 million (A$36.5 million) in an oversubscribed initial public offering. Palo Alto, Calif.-based AirXpanders said it floated 73 million shares at 39¢ (A50¢) apiece, with an indicated full-diluted market capitalization of $87.7 million (A$113 million). “We are delighted with the strong response to this IPO. […]
NIH Researchers design placenta-on-a-chip to study pregnancy
The National Institutes of Health said today that researchers have developed a novel “placenta-on-a-chip” to study the human placenta and its role in pregnancy. The device is designed to imitate the structure and function of human placenta and model nutrient transfer on a micro-level, the NIH said in a news release. “We believe that this technology may […]