Bioceptive Gets FDA Nod for New Women’s Health Device

New Orleans devicemaker Bioceptive plans to roll out its suction cervical retractor later this year, following the receipt of FDA 510(k) clearance, the company said Monday. The device replaces the standard cervical tenaculum forceps used for gynecological procedures.

The device uses gentle suction to engage the cervix, creating an easier way to perform endometrial biopsies, IUD insertions and fertility and other procedures — a more comfortable contrast to forceps, which pierce and clamp cervical tissue to stabilize the cervix and uterus, Bioceptive said.

Bioceptive hopes the device will serve as the basis of a pipeline of products currently under development and preclinical testing. Future product will pair with the retractor to perform a variety of diagnostic and therapeutic procedures, the company said. One such device is an insertion system for intrauterine devices that replaces the four to five instruments used in IUD procedures. — Kellen Owings