FDA clears low-pressure HSG device
Women’s medical device developer Femasys has received FDA 510(k) clearance to market its FemChec Pressure Management Device, designed for a low-pressure HSG test.
The product provides confirmation after a permanent sterilization procedure is performed, according to the Atlanta-based Femasys. It uses technology that limits applied intrauterine pressure to provide confirmation that a physician will not overpressurize the uterine cavity to obtain required images.
The product may reduce improperly performed tests and procedure complications, according to the company.
The FemChec Pressure Management Device will be presented at the American Association of Gynecologic Laparoscopists meeting in Hollywood, Fla., this November.
The product provides confirmation after a permanent sterilization procedure is performed, according to the Atlanta-based Femasys. It uses technology that limits applied intrauterine pressure to provide confirmation that a physician will not overpressurize the uterine cavity to obtain required images.
The product may reduce improperly performed tests and procedure complications, according to the company.
The FemChec Pressure Management Device will be presented at the American Association of Gynecologic Laparoscopists meeting in Hollywood, Fla., this November.