Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide said today it won FDA investigational device exemption approval for its Athena clinical trial testing its Mentor MemoryGel breast implants. The Mentor MemoryGel beast implants are designed for breast reconstruction patients with larger chest widths, larger breast sizes, higher BMI or greater amounts of removed mastectomy tissue, the company […]
Women's Health
Sientra jumps on return to U.S. market
Sientra (NSDQ:SIEN) shares jumped today after the breast implant maker said all of its products are slated to go back on the U.S. market March 1, 4 months after Brazilian regulators shut down production at its sole supplier. Santa Barbara, Calif.-based Sientra tapped new CEO Jeffrey Nugent shortly after Brazilian regulator Anvisa last October suspended production at Silimed, Sientra’s […]
Boston Scientific, Bard escape joint pelvic mesh trial
Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR) yesterday won the 1st trial in a pelvic mesh lawsuit against 2 companies after a Kansas City jury voted 10-2 that their implants were not defective and didn’t cause plaintiff Eve Sherrer’s injuries. Sherrer alleged that Bard’s Align and Boston Scientific’s Solyx products used a polypropylene mesh that reacts to tissue by […]
Johnson & Johnson to pay $120m in 1st mesh settlement
Johnson & Johnson (NYSE:JNJ) is making the 1st move in settling thousands of lawsuits from women who claim the company’s vaginal-mesh inserts caused organ damage and serious pain, paying $120 million to settle the 1st 2,000 to 3,000 suits, according to Bloomberg. The company still faces over 40,000 suits related to vaginal meshes, and its […]
Judge boots Boston Scientific counterfeit mesh case to the FDA
A federal judge yesterday booted a purported class-action racketeering lawsuit filed against Boston Scientific (NYSE:BSX), accusing the medical device maker of illegally smuggling counterfeit resin made in China to make pelvic mesh. The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective […]
LifeImage picks up mammography medical exchange network Mammosphere
LifeImage said today it picked up national mammography and women’s imaging medical exchange network Mammosphere for an undisclosed amount. The acquisition will open up Mammosphere’s existing network, which allows healthcare providers and patients access to prior mammograms, to all healthcare providers currently using LifeImage’s own platform, the company said. “The availability of prior mammograms is critical […]
FDA clears next-gen Pelvalon incontinence device
Pelvalon said yesterday it won FDA 510(k) for its next-generation Eclipse incontinence device designed for women suffering loss of bowel control. Sunnyvale, Calif.-based Pelvalon’s Eclipse is designed to be vaginally inserted, with a balloon that is inflated to put pressure on the rectal wall and prevent involuntary bowel movements. The new version includes a trial insert […]
Appeals court upholds $2m pelvic mesh award against Bard
A federal appeals court last week upheld a $2 million loss for C.R. Bard (NYSE:BCR) in a product liability lawsuit brought over its Avaulta pelvic mesh. A jury awarded plaintiff Donna Cisson $250,000 in compensatory damages and $1.75 million in punitive damages back in August 2013, in 1 of the 1st of thousands of federal lawsuits […]
Boston Scientific smuggled counterfeit resin for pelvic mesh, racketeering lawsuit alleges
A purported class-action racketeering lawsuit filed this week accused Boston Scientific (NYSE:BSX) of illegally smuggling counterfeit resin made in China to make pelvic mesh, after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans. The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the […]
Philips launches mobile obstetrics monitor in Indonesia
Royal Philips (NYSE:PHG) said today it inked a deal with West Sumatra, Indonesia-based Sijunjung Regency to launch its Mobile Obstetrics Monitoring service in the region. The service is designed to identify expecting mother who are at risk of pregnancy related complications to help lower maternal mortality rates, and is smartphone-based and scaleable, Philips said. Philips […]
iCad closes VuComp cancer portfolio buyout
iCad (NSDQ:ICAD) said today it completed its acquisition of VuComp’s cancer detection portfolio, including the M-Vu computer aided detection technology platform. The buy includes a library of related clinical data as well as VuComp’s key personnel and existing customer base. iCad had previously acquired VuComp’s M-Vu breast density software product in April last year. “This […]