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. […]
These young medtech companies raised the most money in 2019
Medical device industry insiders may very well remember 2019 as the year that IPOs came back — but another sign that the U.S. economy has left the Great Recession far behind. Among the top investment deals in the space, half involved public offerings, according to the MoneyTree report from PricewaterhouseCoopers (PwC) and CB Insights. Total investments […]
Study: FDA should have banned pelvic mesh long before it did
Researchers who conducted a long-term study of women implanted with transvaginal mesh to treat pelvic organ prolapse (POP) concluded that the FDA should have banned the product sooner than it did. The study of 54,194 women in New York State revealed that women treated with mesh had an 8.8% risk of reintervention 5 years after […]
Invo Bioscience to study extended use of fertility system
Invo Bioscience (OTCQB:IVOB) has received FDA approval to begin a clinical trial of its modified InvoCell system. The trial will measure InvoCell’s effectiveness in achieving fertilization, implantation, embryo development, clinical pregnancy and live birth after 5 days of continuous vaginal incubation, according to the Sarasota, Fla.-based company. The device is currently cleared for 3-day use. The […]
Contura wins FDA premarket approval for hydrogel injection
Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress urinary incontinence (SUI). Bulkamid is Contura’s proprietary device designed for treating SUI due to intrinsic sphincter deficiency in adult women with SUI or stress predominant mixed incontinence. According to a news release, the product is currently marketed in more […]
Hologic Q1 results are a mixed bag
Hologic (NSDQ:HOLX) posted first quarter results this evening that either matched or beat the consensus forecast on Wall Street, upping its earnings forecast for the year while cutting its projected revenue range. The Marlborough, Mass.–based women’s health medtech company reported profits of $385.8 million, or $1.43 per share, on sales of $850.5 million for the three […]
Invo Bioscience signs Indian distribution deal
Invo Bioscience (OTCQB:IVOB) recently announced that it has inked a joint venture with Medesole Healthcare and Trading Private Limited to market and distribute the InvoCell in vivo fertility system in India. The joint venture will be called Medesole Invo Bioscience India Private Limited and is expected to open and operate dedicated InvoCell clinics only in India, […]
Bayer wins N.J. Essure case on appeal
A New Jersey appeals court has thrown out a woman’s product liability lawsuit against Bayer (ETR:BAYN) over its Essure permanent birth control device. Arcelia Sandobal Gomez had the Essure metal coils implanted in her fallopian tubes in 2014 and claimed she suffered intermittent and severe abdominal pain and chronic and abnormal vaginal bleeding afterwards. Gomez […]
J&J’s Ethicon defeats all but 4 claims in Kentucky pelvic mesh case
A federal judge in Kentucky has dismissed all but four claims in a pelvic mesh lawsuit against Johnson & Johnson’s (NYSE:JNJ) Ethicon division. Jensesta Cutter had Ethicon’s Prolift pelvic mesh implanted in 2006 and complained to her doctor that year of pelvic pain, soreness and burning, constipation and urine leakage, according to the complaint. In […]
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