Hologic (NSDQ:HOLX) said today it won CE Mark approval in the European Union for its MyoSure Manual device. The MyoSure Manual device features an integrated vacuum with no external suction required, the Marlborough, Mass.-based company said. The system is supported by a one-liter bag of saline without the need for a controller or fluid management equipment. “There […]
Women's Health
TherapeuticsMD submits NDA for hormone therapy to treat vasomotor symptoms
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.
Gynesonics submits 510(k) premarket notification for uterine fibroid treatment
Gynesonics announced that it has submitted its 510(k) Premarket Notification to the FDA for its Sonata System. The Sonata System is a uterus preserving, incision-free uterine fibroid treatment that was designed to treat fibroids transcervically with radiofrequency energy. “Submission of the 510(k) application is an important milestone for our company,” Chris Owens, president and CEO […]
TherapeuticsMD shares tumble after FDA pushes NDA decision to mid ’18
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 […]
Boston Scientific settles over 370 pelvic mesh lawsuits
A federal judge in West Virginia this week dismissed approximately 378 recently settled lawsuits against Boston Scientific (NYSE:BSX) over supposed defective pelvic mesh implants, according to court documents released yesterday. Pelvic mesh implants are used to treat pelvic organ prolapse and female stress urinary incontinence, and have been the source of a number of lawsuits which […]
Viveve touts sub-analysis results from Viveve system vaginal laxity trial
Viveve (NSDQ:VIVE) today announced results from a sub-analysis of its Viveve 1 trial exploring the use of the Viveve system for treating vaginal introitus in women with sexual dysfunction, touting improvements on the Female Sexual Functions Index. The Englewood, Colo.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus. Sub-analysis results […]
British health watchdog recommends vaginal mesh ban
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 […]
Hologic wins FDA 510k for Quantra 2.2, inks dev & distro deal with Clarius
Hologic (NSDQ:HOLX) said recently that it won FDA 510(k) clearance for its Quantra 2.2 breast density assessment software and that it inked a development and distribution deal with Clarius Mobile Health for its wireless, handheld ultrasound scanner. The Marlborough, Mass.-based company said the Quantra 2.2 software uses a proprietary algorithm to analyze mammography images for the […]
FDA clears Cianna Medical’s Savi Scout breast cancer locator for long term implants
Cianna Medical said today that the Savi Scout reflector, part of its system for wire-free breast tumor localization, won FDA clearance as the first non-radioactive implant without a restriction on the length of time that the reflector can remain in a patient’s breast. The new clearance means that doctors can place Scout to mark a […]
EMD Serono wins FDA nod for redesigned pen injector
Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector. The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving 86 […]
7 medtech stories we missed this week: Nov. 3, 2017
From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Hologic launches new MyoSure device Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed […]