Limitations in the FDA’s adverse event reporting system for medical devices helped allow the widespread use of laparoscopic power morcellators for years before the risk that they can spread cancer became known, a government watchdog said this week. Medical device manufacturers and importers are required to tell the FDA about any device-related adverse events within 30 days. “FDA […]
Women's Health
UM Baltimore, SurgiGyn ink licensing deal for laparoscopic hysterectomy device
Gynecological surgery device developer SurgiGyn said today it inked an exclusive license arrangement with the University of Maryland, Baltimore for laparoscopic surgical device technology developed at the University. The Baltimore, Md.-based company said it also closed a seed round of funding from UM Ventures and a private investor, with funds slated to support accelerated development […]
Halt Medical wins Medicaid coverage for Acessa treatment in 5 states
Halt Medical said today it won coverage for its Acessa System from Medicaid in Texas, Ohio, Michigan, Indiana and Washington D.C. The Acessa system uses radiofrequency ablation guided by ultrasound to remove fibroids, which are benign, non-cancerous tumors that occur in women’s uteri, often during childbearing years, Brentwood, Calif.-based Halt Medical said. The company said the coverage […]
Guided Therapeutics inks exclusive distro deal with Shandong Yaohua
Guided Therapeutics (OTC:GTHP) said last week it inked an exclusive distribution, sales and manufacturing rights deal for its LuViva advanced cervical scan system with Shandong Yaohua Medical Instrument Corp. Through the deal, Shandong Yaohua will retain exclusive distribution, sales and manufacturing rights in China, Taiwan, Hong Kong and Macau. The deal includes a $1 million licensing […]
Elekta wins FDA 510(k) clearance for Venezia gynecological brachytherapy applicator
Elekta (STO:EKTA B) said today it won FDA 510(k) clearance for its Venezia applicator for gynecological brachytherapy, now cleared for the treatment of advanced-stage cervical cancer. The company’s Venezia device is designed to facilitate pre-defined, consistent needle placement for interstitial brachytherapy and to allow operating clinicians the ability to access tumors that extend outside of the […]
Volpara touts study showing benefits for density scanning before mammograms
Volpara Solutions today released results from a study of its Volpara Density measuring software, touting the benefits of the software for improving mammography performance measures. The study included 111,898 mammograms from 53,239 women who were part of the Dutch Breast Screening Program, the New Zealand-based company said. Results from the study suggest that automatically measuring […]
AirXpanders lands $34m private placement
AirXpanders (ASX:AXP) said today that it has commitments from investors in a private placement to raise A$45 million, or $34 million USD. The Palo Alto, Calif.-based company said that its investors committed to subscribe for 16.3 million shares of common stock at ¢70 apiece. The company plans to use the funds to bring its breast tissue […]
Appeals court upholds $3m verdict against J&J’s Ethicon in pelvic mesh case
A federal appeals court yesterday upheld a $3.3 million verdict against Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in a product liability lawsuit brought over its TVT-O pelvic mesh. A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.3 million, finding in September 2014 that the TVT-O transvaginal sling caused her […]
Elucent Medical raises $7.2 in Series A for next-gen breast clip device
Breast cancer-focused medical device startup Elucent Medical has raised $7.2 million in a Series A round of financing, according to an Xconomy report. The funding round for the Eden Prairie, Minn.-based company closed late last year, according to Xconomy, who spoke to co-founder and CEO Laura King. Elucent is developing a more sophisticated version of […]
Femasys Inc. raises $4m
Femasys Inc. said last week that it raised $4 million, according to a regulatory document filed with the SEC. Atlanta-based Femasys wrote that 8 investors contributed to the round and that it paid Los Angeles-based investment bank Salem Partners LLC an estimated $200,000 in sales commissions. The 1st sale in the financing round happened on Jan. 6 […]
AirXpander’s AeroForm tissue expander transforms decades-old procedure
For 40 years, plastic surgeons have used saline injections to expand tissue and prepare patients for breast implants following mastectomies. These tissue expanders consist of a silicone shell with a magnet and a self-sealing port; a doctor uses a different magnet above the skin to access the port and inject saline to stretch the skin. The […]