News
Femasys Receives FDA 510(k) Clearance for First Low Pressure HSG Device
November 7, 2011 – 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.
Femasys and Norgenix Announce Distribution Agreement for Groundbreaking New Device for Infertility Diagnosis
August 16, 2011 – Femasys Inc. and Norgenix Pharmaceuticals, LLC today announced an agreement for exclusive distribution rights in the United States as well as US territories and military bases for Femasys' FemVue™ Saline-Air Device. This FDA cleared device is used to evaluate a woman's fallopian tubes with standard ultrasound, called a Sono HSG.
May 2, 2011 – 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.