OSPHENA HAS NEW INDICATION
Duchesnay Inc. has added moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA), due to menopause, to the indication of OsphenaTM (ospemifene). The US Food and Drug Administration (FDA) approved Duchesnay’s supplemental New Drug Application in early 2019. Prior to this approval, Osphena was indicated only for the treatment of moderate to severe dyspareunia (painful intercourse), also a symptom of VVA, due to menopause. Osphena is nonhormonal and helps to improve vaginal tissues by increasing superficial cells, decreasing parabasal cells, and reducing vaginal pH, according to Duchesnay. The prescribing information for Osphena includes a boxed warning regarding endometrial cancer and cardiovascular disorders. Duchesnay encourages the reporting of negative adverse effects of prescription drugs to the FDA (www.fda.gov/medwatch).
FOR MORE INFORMATION, VISIT: https://www.osphena.com/.
NEW 3-IN-1 HYSTEROSCOPE
Hologic has a new 3-in-1 hysteroscope (OmniTM), which became available for use in the United States in late 2018 after 510(k) clearance by the FDA. The device features a flexible, modular design offering powerful visualization with 3 sheath options to see and treat pathology, says Hologic. No longer will a physician be required to use a diagnostic scope to look in the uterine cavity for fibroids or polyps, and then switch to an operative scope to biopsy or treat the pathology. Omni’s sheaths also are designed with smaller diameters (3.7 mm diagnostic sheath; 5 mm operative sheath; 6 mm operative sheath) to reduce required dilation, promoting patient comfort. In addition, the device features a long (200 mm) working length to facilitate access and treatment in obese patients, according to the manufacturer. Consult the device’s instructions for use benefit and risk information.
FOR MORE INFORMATION, VISIT: https://gynsurgicalsolutions.com/product/omni-hysteroscope/.
SURGICAL RF TECHNOLOGY
FDA-cleared TempSure™ Surgical RF Technology is now available in North America, Hologic’s Cynosure division announced. The TempSure radiofrequency platform provides clinicians with the ability to perform both surgical and nonsurgical aesthetic procedures across a variety of specialties, on a single device, says Hologic. Cynosure also has returned TempSure™ Vitalia hand pieces and probes to the market and will continue to market its MonaLisa TouchTM CO2 laser following the FDA’s inquiry on products used in energy-based women’s health procedures. Cynosure says that it has worked closely with the FDA and reviewed and updated all of its marketing and promotional materials to ensure that they are consistent with the FDA’s labeling expectations.
FOR MORE INFORMATION, VISIT: https://www.cynosure.com/tempsure-platform.
PROFESSIONAL FOOT SUPPORTS
comenityMED™ announces the release of Resilient™ Professional Foot Supports. The foot supports are the first all-silicone medical exam table stirrup cover that provides patients with support during office-based exams and procedures. Attaching securely to exam table stirrups by means of stretch attachment, the platform ergonomically cradles the foot, increasing patient comfort and satisfaction and offering a professional appearance and slip resistance, says comenityMED. The supports are designed to undergo a high level of disinfection by means of chemical or heat sterilization between patients and conveniently fold back into the bed, according to the manufacturer.
FOR MORE INFORMATION, VISIT: https://www.comenitymed.com.
