The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements. One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of […]
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 […]
Cutera, Senseonics and more receive Paycheck Protection Program loans
A number of medtech companies announced that they received millions of dollars in loans through the Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security (CARES) Act. Cutera (NSDQ:CUTR), Senseonics (NYSE:SENS), Viveve Medical (NSDQ:VIVE) and Encision (ECIA:ECIA) received approximately $15 million combined through the program administered by the U.S. Small Business Administration amid the COVID-19 pandemic. […]
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 […]
How will coronavirus affect medtech companies that rely on elective surgeries?
One thing is likely to hurt some medtech companies more than others during the coronavirus pandemic: an elective surgical procedure slowdown. This thought had begun to emerge last week among industry watchers, but a pair of tweets over the weekend gained thousands of “likes” and retweets. The American College of Surgeons called for hospitals to […]
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. […]
Dexcom lands CE Mark for continuous glucose monitor use by pregnant women
Dexcom (NSDQ:DXCM) said Friday that its G6 continuous glucose monitor system has received the CE Mark for use during pregnancy, and will be available soon, starting with the United Kingdom in Spring 2020. Glucose levels are hard to manage in pregnancy due to the increasing need for and resistance to insulin. Poorly controlled glucose levels in […]
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