(Reuters) — Women implanted with Bayer‘s (ETR:BAYN) Essure female sterilization device were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization, according to a study published today in the British Medical Journal. The findings could cast additional doubt on the safety of the Bayer device, which was approved in 2002 as […]
Gynecological
Report: Feds to investigate power morcellators
The Government Accountability Office said last week it will investigate potential safety and regulatory issues with laproscopic power morcellators, according to The Wall Street Journal. The devices use small, rotating blades to break up large tissue masses into fragments, and are commonly used to remove uterine fibroids in women. However, if the device is used […]
Gynesonics raises $43m
Gynesonics said today it raised $43 million in a new round of equity financing, with funds slated to aid the company’s operations and support its Sonata radiofrequency ablation device used to treat intrauterine fibroids. The Sonata system is minimally invasive and incision-free, using radiofrequency ablation guided by sonography and preserving the uterus, unlike hysterectomies which […]
Channel Medsystems raises $23.8m
Channel Medsystems raised $23.8 million in a new equity financing round, where it is seeking $29.5 million, according to an SEC filing. The company is developing a global cryogen-based endometrial ablation technology system, with an initial application of endometrial ablation for women with heavy menstrual bleeding, Emeryville, Calif.-based Channel Medsystems said. Channel Medsystems found 23 unnamed […]
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 […]
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 […]
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 […]