AirXpanders said the pivotal investigational device exemption trial of its AeroForm tissue expander met its primary endpoint. Results from the trial were presented at the American Society of Plastic Surgeon’s meeting in Boston. The AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to […]
Women's Health
Jury finds for Boston Scientific in pelvic mesh case
A federal jury in North Carolina last week found for Boston Scientific (NYSE:BSX) in a product liability lawsuit filed over its Uphold pelvic mesh. Plaintiff Martha Carlson’s 2013 lawsuit was consolidated with another case in May. Carlson alleged that her injuries were caused by the Uphold product after its implantation in 2010 in a Charlotte hospital. […]
Study finds higher surgery risk with Bayer’s Essure
(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 […]
Gamma Medica’s LumaGEM breast cancer imaging device wins CE Mark
Gamma Medica said it won CE Mark approval in the European Union for its LumaGEM molecular breast imaging system. The device is designed to eliminate shortcomings in mammography systems for women with dense breast tissue, which Salem, N.H.-based Gamma Medica said make up approximately 50% of all women. Dense breast tissue has been linked to […]
Insightec wins expanded FDA nod for Exablate device
Insightec said today it won expanded FDA premarket approval for its next generation Exablate system used to treat symptomatic uterine fibroids for patients who wish to retain their uterus and fertility. The Exablate system uses both focused ultrasound to ablate fibroid tissue and magnetic resonance imaging to guide the ultrasound ablation to specific tissue targets, the […]
Scottish Gov’t to limit pelvic mesh implants
The Scottish Government’s safety review group said it will no longer recommend 3 of the 4 pelvic mesh procedures performed routinely in Scottish hospitals for patients with pelvic organ prolapse and stress urinary incontinence. The change came after the Scottish Government launched an expert review group to analyze the use of the mesh to treat pelvic […]
Johnson & Johnson wins 1st Prosima pelvic mesh suit
Johnson & Johnson (NYSE:JNJ) reportedly won the 1st lawsuit to go to trial over its Prosima pelvic mesh implant, after a Texas state jury ruled yesterday that the device was not defectively designed and that J&J subsidiary Ethicon’s risk warnings were adequate. The Dallas County District Court jury’s 10-2 verdict rejected claims by plaintiff Carol Cavness that Ethicon’s Gynecare Prosima […]
Seno Medical completes Imagio pivotal trial
Seno Medical said Tuesday it completed the final phase of the pivotal trial of its Imagio opto-acoustic breast imaging platform designed to help prevent unnecessary biopsies. The Imagio system combines traditional ultrasound with light-based imaging, providing physicians with a closer look at “suspicious” breast masses without subjecting patients to radiation, injectable contrast agents or invasive […]
Study: Computer-aided mammograms fail to improve detection, raise costs
Computer-aided breast cancer screening technology designed to boost accuracy have failed to increase detection, according to a new study published yesterday in the journal JAMA Internal Medicine. The technology, from companies like Hologic (NSDQ:HOLX) and iCad (NSDQ:ICAD) failed to improve detection of cancerous tumors, according to the report. “We found no evidence that CAD applied to digital […]
NIH invests $46m in placenta-monitoring tech sponsorship
The National Institutes of Health said today it will grant $46 million in research awards for its newly created Human Placenta Project to support developing technology to assess placental function throughout pregnancy. The program aims to improve pregnancy outcomes and lifelong health with the research and investigate issues like preeclampsia, preterm birth and stillbirth, which […]
Sientra plummets on U.K. breast implant halt
Shares of breast implant maker Sientra (NSDQ:SIEN) plummeted some 53% yesterday after British medical regulators suspended sales of implants made by Sientra’s Brazilian supplier Silimed. The U.K.’s Medicines & Healthcare Products Regulatory Agency yesterday said it and other European regulators are testing Silimed’s products – which include breast, penile and testicular implants – after contamination was detected during an audit of […]