Invo Bioscience (Nasdaq:INVO) announced that the FDA granted 510(k) clearance to expand the labeling on its InvoCell device.

Sarasota, Florida-based Invo’s InvoCell indication now includes a five-day incubation period. Data supporting this clearance demonstrated improved patient outcomes for the device, which previously had a three-day incubation period.

The company designed InvoCell to allow fertilization and early embryo development to take place in vivo within the woman’s body. InvoCell won FDA de novo approval in November 2015 and launched in the U.S. in April 2016.

“This is a momentous day for Invo as the FDA has provided clearance for us to expand our labeling to cover a 5-day incubation period for InvoCell,” said Steve Shum, CEO of Invo. “This has been a multi-year effort to demonstrate InvoCell’s ability to improve patient outcomes using a longer incubation period, similar to conventional IVF results. We believe our ability to now communicate the improved success rates using InvoCell to patients and physicians will have a positive effect on the overall confidence and adoption of the technology going forward.”

Shum added that industry trends for conventional IVF moved toward a five-day incubation period over time. This proved to improve pregnancy success rates, he explained. Off-label use of InvoCell included five-day incubation, which demonstrated improved outcomes. That enabled Invo Biosciences to use real market usage data to support its FDA submission.

“We believe the recent 510(k) clearance will help further support our overall commercial activities,” said Shum.