The FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse. According to a document from the U.S. regulatory watchdog, the committee will be tasked with assessing the benefits and risks of placing mesh transvaginally in the […]
Hologic wins FDA nod, launches next-gen Omni hysteroscope
Hologic (NSDQ:HOLX) said today that it launched its next-gen Omni hysteroscope in the U.S. after having received FDA 510(k) clearance earlier in the month. The newly cleared Omni hysteroscope features a three-in-one modular scope and is intended for both diagnostic and therapeutic procedures, the Marlborough, Mass.-based company said. “Experts agree that direct visualization of the uterine […]
Viveve prices $20m offering
Viveve (NSDQ:VIVE) last week priced a follow-on offering worth $20 million. Englewood, Colo.-based Viveve’s eponymous device uses cryogen-cooled monopolar radiofrequency tech designed to treat gynecological conditions. The company said Dec. 6 that it floated 13.3 million shares at $1.50 apiece, for gross proceeds of $20.0 million. The offering includes a 30-day underwriters option on another 2.0 […]
Report: FDA-reported breast implant injuries kept hidden by summary reporting
The number of medical device reports sent to the FDA concerning issues with breast implants was kept artificially low through the use of summary reporting, according to a new report from the Honolulu Star Advertiser. Between 2008 and 2015, the FDA received an average of approximately 200 medical device reports related to breast implants, significantly […]
FDA clears Thermi in “vaginal rejuvenation” product inquiry
Temp-controlled radiofrequency tech developer Thermi said this week that the FDA granted it a notice of completion following an inquiry on products used in “vaginal rejuvenation” procedures. Irving, Texas-based Thermi received a notice from the FDA on July 24 regarding specific claims about the company’s ThermiVa device. The ThermiVa is a non-ablative RF device cleared […]
Merit Medical closes $200m Cianna Medical buy
Merit Medical (NSDQ:MMSI) said yesterday that it closed its $200 million acquisition of Cianna Medical, making the company a wholly-owned subsidiary. Aliso Viejo, Calif.-based Cianna makes the Savi Scout wire-free breast tumor localization system, designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy and biopsy procedures. The device won 510(k) clearance from […]
Aegea Medical raises $17m, touts 3-year adaptive vapor ablation pivotal results
Aegea Medical said this week it raised $17 million in a new financing round and released three-year follow-up data from the pivotal study of its Adaptive Vapor Ablation technology designed for use in endometrial ablation procedures. The funding round was led by Solas BioVentures and its affiliates, with funds slated to support the company’s PACE II […]
Pa. State Judge orders new trial in J&J pelvic mesh case
A state judge in Pennsylvania this week ordered a new trial in a suit alleging a that a woman was injured by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon’s TVT-Secur pelvic mesh implant. The jury had previously ruled that the TVT-Secur device was defective in design and that the company did not appropriately warn pelvic floor surgeons of […]
INVO Bioscience touts two women’s ability to carry the same baby
INVO Bioscience today announced that a child had been born to a same-sex couple in which both partners were able to carry the baby in separate phases of the pregnancy. The couple, Bliss and Ashleigh Coulter of Mountain Springs, Texas, welcomed their son, Stetson, in late October. The women and their doctors used INVO Bioscience’s […]
Aegea Medical launches post-market Adaptive Vapor Ablation study
Aegea Medical said today that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures. The PACE II study will look to enroll up to 50 women who were previously treated in the Menlo Park, Calif.-based company’s pivotal trial of the Adaptive Vapor Ablation tech and […]
Philips launches all-in-one breast ultrasound system
Royal Philips (NYSE:PHG) said yesterday it launched an all-in-one breast assessment solution designed for use with its Epiq and Affiniti ultrasound systems. The newly launched solution, which has received CE Mark approval in the European Union and FDA 510(k) clearance in the US, is intended for the assessment, monitoring and treatment of breast diseases, the Amsterdam-based […]
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