Women’s healthcare company Gynesonics (Redwood City, Calif.) said it has received 510(k) clearance from the FDA to market its Sonata sonography-guided transcervical fibroid ablation system. Sonata combines a breakthrough integrated technology — the first intrauterine ultrasound system — with a proprietary radiofrequency ablation device, providing a transcervical, incision-free, uterus-preserving treatment for uterine fibroids, the company […]
Alpha Tau Medical can begin U.S. clinical trials of its cancer-zapping device, thanks to a new permit from the Massachusetts Radiation Control Program. The state agency granted a Sealed Source and Device (SSD) approval to the Tel Aviv company’s Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy), which enables alpha-radiation-based cancer treatment for various types of solid […]
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial […]
Labor, delivery and neonatal intensive care devices company Clinical Innovations (Salt Lake City) has acquired Australian distributor JB Medical Supplies. The deal, announced yesterday, is meant to bolster Clinical Innovations’ position in Australia. JB Medical Supplies will operate as a wholly owned subsidiary of Clinical Innovations. Financial terms of the deal were not disclosed. Get the full story […]
Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology. Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013, […]
TherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause. The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule. Get the full story at our sister site, Drug Delivery Business News.
TherapeuticsMD (NSDQ:TXMD) shares fell -7% yesterday after the company announced that the FDA accepted its resubmitted application for TX-004HR, an investigational, applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia. The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response – a Class 1 response would […]
A British health watchdog reportedly plans to recommend that the National Health Service there ban vaginal mesh implants to treat pelvic organ prolapse, citing “serious but well-recognized safety concerns.” In recommending that the implants be limited to research use only, the U.K.’s National Institute for Health & Care Excellence said “evidence of long-term efficacy [for implants […]
Teva Pharmaceuticals (NYSE:TEVA) said today that it closed the $675 million cash sale of its Plan B One-Step product and emergency contraception assets to Foundation Consumer Healthcare. The move is part of Teva’s efforts to restructure its business, narrowing its focus on CNS and respiratory conditions. The company also plans to divest of its oncology and […]
Teva Pharmaceuticals (NYSE:TEVA) said today that it closed the $1.1 billion cash sale of its Paragard intrauterine copper contraceptive device to Cooper Cos.‘ (NYSE:COO) CooperSurgical unit. The deal included Teva’s manufacturing facility in Buffalo, N.Y., the pharma company reported. The move is part of Teva’s efforts to restructure its business, narrowing its focus on CNS and respiratory […]
Agile Therapeutics (NSDQ:AGRX) touted data today from a Phase III trial of its once-weekly, low-dose hormonal contraceptive patch, Twirla. The study showed that women experienced mean decreases in length of bleeding and spotting episodes, the Princeton, N.J.-based company reported. Get the full story at our sister site, Drug Delivery Business News.