Femasys Announces FDA 510(k) Clearance of New Device for In-Office Diagnostic Sono HSG Test for Evaluating Fallopian Tubes
ATLANTA, May 2, 2011 /PRNewswire/ --Femasys Inc., an emerging medical device developer of women's healthcare solutions, announced today the 510(k) clearance of FemVue™ Saline-Air Device for a diagnostic Sono HSG allowing physicians to evaluate a woman's fallopian tubes with existing ultrasound equipment. The product allows for a cost-effective, convenient, and safe (non-radiation) Sono HSG procedure to be performed quickly by a woman's gynecologist or infertility specialist in the office.
Concerns over fertility affects an estimated 10 million women (U.S.) with the most common infertility factor reported as fallopian tube blockage. Until now, women's tubes were evaluated by fluoroscopic HSG in a medical imaging center requiring a procedure referral. FemVue Sono HSG has the potential to change the standard of care by moving the assessment to the office where all female infertility factors can be evaluated by her gynecologist.
Commenting on the announcement, Kathy Lee-Sepsick, President & CEO of Femasys Inc., said, "The FemVue clearance for commercialization represents a significant step forward for the growth of the company. FemVue not only provides the physician an ability to expand services but allows for a comprehensive and appropriate plan of care, saving time and cost for the patient, both invaluable for couples dealing with infertility issues."
Dr. Charles E. Miller, President and Medical Director of the Advanced Gynecologic Surgery Institute, commented, "I see FemVue as a marked improvement over standard fluoroscopic HSG. It allows me the ability, in the office, to precisely evaluate the cavity, myometrium, and for the first time fallopian tubes. It is my diagnostic procedure of choice for evaluating fallopian tubes."
Early limited U.S. commercialization efforts have been extremely positive, with over 40 physicians in 31 states utilizing FemVue. Along with the CE mark, this 510(k) clearance allows Femasys to expand commercialization efforts worldwide. The company is actively seeking distribution partners.
Femasys is a privately held corporation committed to advancing women's healthcare with innovative medical devices designed, manufactured, and commercialized for use in the physician's office. The company is continually researching and developing cost-effective new products designed for women, often expanding in-office services that physicians can easily incorporate.
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SOURCE Femasys Inc.