Interim results from a postmarket study of the Bayer (ETR:BAYN) Essure permanent birth control device revealed higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared with laparoscopic tubal ligation as permanent birth control. The FDA posted the results as part of a long-term safety evaluation of the device, which has […]
AdaptHealth prices $124m upsized offering
AdaptHealth (NSDQ:AHCO) announced today that it upsized and priced an underwritten offering of common stock at approximately $124 million. Plymouth Meeting, Pa.-based AdaptHealth is offering 8 million shares of its Class A common stock at $15.50 per share. The maker of home medical equipment, supplies and related services had previously set the offering at 6.5 […]
Gynesonics lands FDA clearance for fibroid-removal system
Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical fibroid ablation (TFA). Redwood City, Calif.-based Gynesonics’ Sonata platform integrates what the company touts as the first and only intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device. The system provides an incision-free, uterus-preserving transcervical treatment for symptomatic […]
Invo Bioscience raises $2.1m
Invo Bioscience (OTCQB:IVOB) filed an SEC Form D to confirm the sale of more than $2.1 million in equity, debt and other warrants and options. The Sarasota, Fla.-based company made its first sale in the new notice on May 15, collecting the more than $2.1 million from eight investors so far. The offering is not being […]
Minerva Surgical closes on Boston Sci intrauterine health franchise buy
Minerva Surgical today said it closed the acquisition of Boston Scientific’s intrauterine health franchise. The financial details of the deal were not disclosed. The new combination of devices includes the Minerva Endometrial Ablation System and the Genesys HTA Endometrial Ablation System for visualization in the uterine cavity during treatment. The deal also includes the Symphion […]
Viveve Medical raises $3.2m
Viveve Medical (NSDQ:VIVE) filed an SEC Form D yesterday to confirm the sale of more than $3.2 million in options, warrants and other rights to acquire other securities. The company made the first sale in the offering on April 20 and has now sold the total offering amount of $3,225,875. There is a sales commission worth […]
Xenocor wins FDA nod for 5 mm articulating laparoscope
Xenocor announced that it received FDA clearance for its Xenoscope disposable 5mm articulating laparoscope for abdominal and thoracic surgery. The Salt Lake City-based company designed its latest laparoscope to improve image quality, reduce fog, lower hospital costs and reduce bio-hazard risk for the patient and staff. Xenocor’s new Xenoscope includes a disposable 5mm camera on […]
Viveve looking at ‘stategic alternatives’ after trial misses the mark
Viveve Medical (NSDQ:VIVE) announced today that the clinical trial for its cryogen-cooled monopolar radiofrequency (CMRF) technology did not meet its primary endpoint. The company added that it is currently evaluating strategic alternatives and assessing its organization and cost structure following the missed endpoint amid the current COVID-19 pandemic. The Viveve II clinical trial is a multicenter, […]
Aegea Medical device to treat heavy menstrual bleeding wins FDA approval
Aegea Medical this week said it won FDA approval for its Mara Water Vapor Ablation System. The Mara System is an endometrial ablation treatment that uses natural water vapor to treat menstrual bleeding. It is designed to be used in a doctor’s office without the need for general anesthesia. Mara is a one-time, two-minute treatment […]
Viveve Medical completes enrollment for study of its stress urinary incontinence treatment
Viveve Medical (NSDQ:VIVE) announced that it completed enrollment in a short-term feasibility study for its cryogen-cooled monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI) in women. The international, three-arm study is a prospective, randomized, single-blind clinical trial comparing Viveve’s CMRF treatment and a cryogen-only sham to an inert sham treatment in women with SU. Englewood, […]
FDA recommends limiting use of power morcellators
The FDA today recommended that laparoscopic power morcellators, which have been implicated in the spread of cancer, be limited to use with certain tissue containment systems and only in premenopausal women under 50 years of age. Power morcellators were used for 20 years to laparoscopically remove benign tumors of the uterus, known as fibroids, by mincing them. […]
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