Bioceptive Receives FDA Clearance for First Medical Device

bioceptiveBioceptive is a New Orleans-based women’s health company developing innovative medical devices for a variety of gynecological procedures. Their first product, a suction cervical retractor, has just received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Preparations for clearance process can take years. The company excited to announce it expects to begin a limited market rollout in late 2015.

The now cleared device is providing a more accessible and safer method for intrauterine device (IUD) insertion. Bioceptive has been working for years on a solution to address adverse effects associated with traditional IUD insertion tools such as a perforation of the uterus during insertion and accidental expulsion and also to improve access to contraception. By incorporating a higher level of accuracy and lower potential for perforation, Bioceptive has developed a safer and easier IUD.

“Bioceptive’s suction tenaculum is a truly novel gynecologic instrument that permits cervical traction without tissue penetration,” David Turok, MD, MPH, an Associate Professor of Obstetrics and Gynecology at the University of Utah has shared. He has worked with the company on ongoing development and clinical efforts. “This device coupled with Bioceptive’s IUD inserter has the potential to revolutionize IUD insertion by dramatically simplifying the process.”

According to the press release, Bioceptive’s patented system will also allow its future devices to pair with its cervical retractor to usher in a new era in intuitive, consistent, safe procedures for a variety of diagnostic and therapeutic procedures.

Bioceptive also has a pipeline of other products in early development and conceptual phases.