Viveve (NSDQ:VIVE) said on Tuesday it launched a trial exploring the safety and efficacy of its cryogen-cooled monopolar radiofrequency tech designed to treat stress urinary incontinence in women. The new Liberate trial will look to enroll 100 subjects at up to 10 sites in Canada, with patients randomized in a two-to-one ratio for active and sham treatments. […]
Invuity launches PhotonGuide Adapt vaginal surgical illuminator and retractor system
Invuity (NSDQ:IVTY) said yesterday it launched the PhotonGuide Adapt system featuring a flexible illuminator and retractors for vaginal surgical procedures. The devices are designed for use in procedures including pelvic organ prolapse repairs and vaginal hysterectomies, the San Francisco-based company said. The PhotonGuide Adept’s waveguide is designed to conform to different sizes and shapes of retractors […]
Report: Women in Australia to pursue class action over Bayer’s Essure
A group of women in Australia will be joining other women worldwide in pursuing a class action lawsuit against Bayer (ETR:BAYN) for medical problems allegedly associated with its Essure permanent birth control device, according to a report from The Guardian. The suit, which will be led by law firm Slater and Gordon, joins similar suits against […]
Hologic pulls Vitalia handpieces, probes in light of FDA concerns over vaginal rejuv tech
Hologic (NSDQ:HOLX) said today that its subsidiary Cynosure is suspending marketing and distribution of its TempSure Vitalia handpieces and probes after the FDA released a warning about a lack of evidence to support certain “vaginal rejuvenation” products late last month. The Marlborough, Mass.-based company said that it takes “the FDA’s recent statements very seriously” and […]
Inside Hologic’s evolving definition of women’s healthcare
Hologic (NSDQ:HOLX), known in the medtech industry for its mammography and diagnostics devices, is rethinking what it means to be a women’s healthcare company. The 6,000-person company wants to expand its reach to include products that care for women’s well-being, as well as their health – a concept that Dr. Edward Evantash honed when he led […]
Viveve wins FDA nod to continue Viveve II trial
Viveve (NSDQ:VIVE) said yesterday it won FDA clearance to continue enrollment in its Viveve II trial exploring the safety and efficacy of its Viveve system for improving sexual function in women following vaginal childbirth. The approval came based off sufficient evidence to support continued enrollment and a lack of subject protection concerns which would preclude continuation, the […]
Hologic drops $85m on Faxitron Bioptics
Hologic (NSDQ:HOLX) said yesterday that it dropped $85 million on Faxitron Bioptics and its line of breast health offerings. Tucson, Ariz.-based Faxitron, which makes digital specimen radiography, breast lesion localization and sentinel lymph node biopsy products, posted sales of roughly $27 million during its last fiscal year. “Faxitron, like Hologic, has built a strong brand focused on improving the […]
FDA warns on ‘vaginal rejuvenation’ procedures
FDA head Dr. Scott Gottlieb today released a statement warning about “vaginal rejuvenation” procedures intended to treat conditions related to menopause, urinary incontinence or sexual function, saying that the products used in the procedures “don’t have adequate evidence to support their use for this purpose.” Gottliebb said that the procedures use lasers or energy-based devices […]
ITC backs Hologic in mammography patent spat with FujiFilm
Hologic (NSDQ:HOLX) said yesterday that a US International Trade Commission Administrative Law Judge ruled in their favor in an investigation into a patent infringement complaint filed against Fujifilm Holdings (TSE:4901). Marlborough, Mass.-based Hologic said the complaint was related to x-ray mammography with tomosynthesis and other related mammography tech found in its Selenia Dimensions and 3Dimensions systems. The […]
Bayer fires back against Essure safety claims
Bayer (ETR:BAYN) last week fired back against claims that its Essure permanent birth control device is less than safe and effective after having announced plans to pull the device from the shelves in the US a week earlier. Last Thursday, the pharmaceutical giant published a press release lauding the device as the only FDA-approved non-incisional form […]
Hologic wins $5m from Minerva Surgical in patent infringement spat
A federal court jury last week awarded Hologic (NSDQ:HOLX) nearly $5 million in damages in a patent infringement lawsuit brought over their respective endometriosis devices. Hologic’s NovaSure ablation device, acquired with the 2007 buyout of Cytyc (which acquired NovaSure developer Novacept in 2004), competes with Minerva’s Aurora device. Hologic sued Minerva in November 2015 in the […]
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