Nov. 7, 2011 /PRNewswire/ — Femasys Inc., an emerging medical device developer
of women’s healthcare solutions, announced today that it has received 510(k)
clearance for the FemChec™ Pressure Management Device, the first device
designed for a low pressure HSG as a confirmation test after a permanent
sterilization procedure is performed. FemChec utilizes patent-pending
technology that limits the applied intrauterine pressure to 200 mmHg, providing
confidence to the physician that he/she will not overpressurize while
adequately filling the uterine cavity and cornu to obtain the required images. FemChec
allows the physician to meet the requirements of the mandatory HSG confirmation
test and may reduce improperly performed tests and procedure complications.
Kathy Lee-Sepsick, Femasys’ President & CEO, commented,
“We have utilized our expertise to respond to the market need for a low
pressure HSG test that can be performed with confidence, taking the guesswork
out of whether low pressure is truly achieved. The FemChec provides clear
benefits to the physician and ultimately the patient as a properly performed
low pressure confirmation test is critical to relying on the permanent
sterilization procedure long-term.”
The FemChec Pressure Management Device will be presented to
the gynecologic community in November at the AAGL meeting in Hollywood, Florida.
Femasys expects the first devices to begin shipping in the U.S. market in
December and is pursuing strategic corporate partnerships for FemChec. The
product is expected to contribute to the growing revenue base of Femasys
branded products. Earlier this year, Femasys launched the FemVue Saline-Air
Device designed to provide gynecologists and their patients with a simple way
to evaluate tubal patency in the office with existing ultrasound. The FemVue product
has been very well received and is being distributed in the U.S. by
Norgenix. The Company is actively seeking other distribution partners for the
rest of the world.
Femasys is a privately held corporation committed to advancing women’s
healthcare with innovative medical devices. The company is continually
researching and developing cost-effective new products designed for women,
often expanding in-office services that physicians can easily incorporate.