Viveve (OTC:VIVMD) today tweaked the value of its uplisting from the over-the-counter exchange to the NASDAQ board, expecting to sell 2.7 million shares at $5 per share to bring in $13.5 million. Sunnyvale, Calif.-based Viveve makes a non-surgical treatment for post-partum laxity of the vaginal introitus. The company put a 1-for-8 reverse split into place in April, and said […]
Women's Health
Boston Scientific updates warnings for pelvic mesh products
Boston Scientific (NYSE:BSX) recently updated the directions for use and warnings for its pelvic mesh products, classifying the meshes as permanent implants and warning of complications related to removals. The Marlborough, Mass.-based company added new precautions to the directions for the meshes, warning that that “regardless of the route of delivery,” the meshes have been associated with […]
Ethicon mesh plaintiffs claim company expert admitted mesh degrades
Plaintiffs in the multi-district litigation brought over the pelvic mesh made by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon claimed this week that a company expert admitted that Ethicon knew back in 1992 that the plastic used in its mesh degrades after implantation. The case concerns damages reportedly caused by Ethicon’s pelvic mesh products. Plaintiffs in […]
Guided Therapeutics inks Chinese Luviva licensing deal
Guided Therapeutics (OTC:GTHP) said today it inked a licensing deal with Shenghuo Medical to manufacture and market its LuViva advanced cervical scan system in China and several other Southeast Asian countries. The deal includes $200,000 in near-term cash payments, up to $1 million to support FDA approval for LuViva and extra support for achieving Chinese regulatory approval […]
Mirabilis Medica raises $5.2m for uterine fibroid treating device
Uterine fibroid-treating device developer Mirabilis Medica raised $5.2 million in a new round of debt financing, according to an SEC filing posted today. The company’s Mirabilis system is designed to use ultrasound to both provide imaging and ablation during procedures to remove uterine fibroids, the company said. The device uses low-intensity ultrasound waves to locate […]
FDA clears Esco Medical’s Miri TL embryo incubator
In vitro fertilization business Esco Medical said today the FDA granted 510(k) clearance to its Miri Time-Lapse embryo incubator. The newly cleared Miri TL is designed as a multi-room incubator with a built-in microscope and camera to continuously capture images of embryo development until the embryo is ready to transfer, the company said. “We are […]
OvaScience closes $53.8m financing round
OvaScience (NSDQ:OVAS) said today it closed a $53.8 million funding round as it looks to expand its Augment treatment in Japan and Canada and support pre-commercial activities for its OvaPrime and OvaTure treatments. OvaScience’s Augment fertility treatment is designed to enhance in vitro fertilization by improving the health of a woman`s eggs, the company said. The treatment draws […]
Smart tampon: Startup seeks to use menstrual cycle to help Dx cervical cancer
A new women’s medical device company, Next Gen Jane, aims to develop a “smart tampon” that can perform blood-based tests for a range of biomarkers to improve women’s health monitoring for conditions like cervical cancer, according to a new report from FastCompany. Founders Ridhi Tariyal and Stephen Gire, who met in an infectious disease lab at […]
OvaScience preps offering to support Augment expansion
OvaScience (NSDQ:OVAS) said today it is opened a new offering of stock as it looks to expand its Augment treatment in Japan and Canada and support pre-commercial activities for its OvaPrime and OvaTure treatments. OvaScience’s Augment fertility treatment is designed to enhance in vitro fertilization by improving the health of a woman`s eggs, the company said. The […]
Viveve boosts terms for $13m NASDAQ uplisting
Updated to correct Scott Durbin’s title to CFO Viveve (OTC:VIVMD) said today that it’s boosting the value of a pending uplisting from the over-the-counter exchange to the NASDAQ board. Sunnyvale, Calif.-based Viveve makes a non-surgical treatment for post-partum laxity of the vaginal introitus. The company put a 1-for-8 reverse split into place last month; today Viveve said it […]
Study: High-risk women’s health devices approved on faulty data
Certain high-risk women’s health devices won FDA approval based on flawed data, according to a new study from Northwestern Medicine. Data from the study was published in the journal Obstetrics and Gynecology. “Devices are a huge part of the medical care that we provide women on a daily basis. We found that there’s an opportunity […]