(Reuters) — Surgical procedures during pregnancy are generally safe, new research indicates. “Clearly, surgery during pregnancy should only be considered if absolutely necessary,” said Dr. Paul Aylin, study co-author and an epidemiologist at the Imperial College London in England. But when expectant mothers do need to undergo surgery, “the information provided in our analysis may give […]
Women's Health
Viveve wins FDA 510(k) for its Viveve System
Viveve (NSDQ:VIVE) said today it won FDA 510(k) clearance for its Viveve System, now cleared for use in general surgical procedures for electrocoagulation and hemostasis. The company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. “FDA 510(k) clearance for the Viveve System represents a major milestone in our efforts to […]
Boston Scientific loses bid to toss $19m pelvic mesh loss
Boston Scientific (NYSE:BSX) yesterday lost its bid to overturn an $18.5 million loss in a product liability lawsuit brought by a quartet of women alleging that its Obtryx pelvic mesh caused their injuries. A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later […]
Allergan wins FDA nod for Natrelle Inspira breast implants
Allergan (NYSE: AGN) said last week that it won FDA pre-market approval for its Natrelle Inspira cohesive breast implants for women undergoing breast reconstruction, augmentation or revision surgery. The newly cleared Natrelle Inspira implants combine both a high gel fill ratio and the company’s cohesive gel to create a customized shape, the company said. “Natrelle […]
FDA approves Bayer’s Kyleena IUD
Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years. The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month. LARCs are an increasingly popular form of birth control, including intrauterine devices like Kyleena. Bayer’s […]
Plaintiff’s loss overturned in Boston Scientific pelvic mesh lawsuit
The plaintiff in the 1st pelvic mesh lawsuit to go to trial against Boston Scientific (NYSE:BSX) won a new trial yesterday when a Massachusetts appeals court overturned a 2014 verdict dismissing the case. Diane Albright alleged that the Pinnacle mesh implanted to treat her pelvic organ prolapse was improperly designed and caused her injuries after it was […]
Viveve hits the market Down Under
Viveve (NSDQ:VIVE) said today it it won regulatory clearance from Australia’s Therapeutic Goods Administration for its Viveve non-surgical treatment for post-partum laxity of the vaginal introitus. The Sunnyvale, Calif.-based company said it inked a distribution partnership deal in Australia and New Zealand with medical product supplier Device Consulting, which will support the regional distribution of the Viveve […]
FDA: No evidence of data manipulation in clinical trials for Bayer’s Essure
The FDA said it completed a review of a trade complaint which alleged that Bayer (ETR:BAYN) was engaged in clinical trial misconduct and altering data, saying it found no signs of manipulation. The agency set out to review the allegations, which accused Bayer of clinical trial misconduct, “notably that clinical trial participants’ medical records were altered […]
Cigna adds reimbursement coverage for 3D breast scans
Cigna (NYSE:CI) said this week that it’s revising its coverage to include 3D mammography for routine breast cancer screening. The Bloomfield, Conn.-based health insurer only reimbursed for 3D breast scans made for diagnosis, based on the U.S. Preventive Services Task Force’s finding that there’s not enough data to show that 3D mammography is better than traditional mammography in […]
Fujifilm files last PMA module for Aspire Cristalle breast tomosynthesis software
Fujifilm Holdings (TSE:4901) said yesterday it filed its last Premarket Approval module to the FDA for its Aspire Cristalle breast tomosynthesis optional software upgrade for its Aspire Cristalle digital mammography system. The optional upgrade is known as the Amulet Innovality outside of the U.S., and has been available since May 2013 in the E.U., Asia and […]
Power morcellation rates plunged after FDA warnings
Use of electric power morcellation for hysterectomy procedures has significantly declined after the FDA warned against the use of such devices in 2014, according to a new study. Data from the study was published this month in the Journal of the American Medical Association. The study examined a total of 203,520 women who underwent hysterectomy […]