Novel Cervical Retractor Device Gets FDA Clearance
Bioceptive announced it has received clearance from the Food and Drug Administration (FDA) for its suction cervical retractor for use in various gynecological procedures.
The new device uses gentle suction to engage the cervix in place of standard cervical tenaculum forceps that pierce and clamp cervical tissue in order to stabilize the cervix and uterus. The retractor device creates an opening into the uterus for instrument use and procedures such as endometrial biopsies, intrauterine device (IUD) insertion, fertility procedures, and others. This patented system will allow future Bioceptive devices to pair with its cervical retractor.
Currently, the company is testing a comprehensive insertion system for IUDs that replaces 4–5 instruments usually used in IUD procedures.
Bioceptive is planning a limited product launch in late 2015.
For more information visit (504) 598-5232 or visit Bioceptive.com.