Bioceptive receives FDA clearance for device

Bioceptive, a women’s health startup led by South Florida medical device entrepreneur Dr. Stewart Davis, received Food and Drug Administration clearance for its first women's health medical device.

Bioceptive is now cleared and able to begin marketing its first device, and it plans to begin a limited market rollout later this year. The device is essentially a gentler suction-based device that could replace cervical tenaculum forceps in a wide array of gynecological procedures. The FDA clearance also paves the way for numerous other devices the startup currently has under development, the company said.

“This device coupled with Bioceptive’s IUD inserter [currently in development] has the potential to revolutionize IUD insertion by dramatically simplifying the process,” said Dr. David Turok, associate professor of obstetrics and gynecology at the University of Utah, who has worked with the company on ongoing development and clinical efforts.

Bioceptive received funding from the Boca Raton-based New World Angels.

Nancy Dahlberg