The expanded five-day incubation clearance was based on data showing enhanced patient outcomes. Credit: bezikus / Shutterstock.com.

INVO Bioscience has received 510(k) clearance from the US Food and Drug Administration (FDA) for expanded use of the INVOcell device.

The approval will allow expansion of the labelling on the device and its indication for use to provide an incubation period of five days.

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The expanded incubation approval was based on data showing enhanced patient outcomes.

Earlier, INVO Bioscience secured De Novo clearance from the FDA for the device for a three-day incubation period.

This treatment solution is claimed to be the world’s first intravaginal culture (IVC) technique for oocytes and sperm incubation during fertilisation and early embryo development.

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With this solution, fertilisation and early embryo development will take place in vivo within the woman’s body.

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Eggs, sperm and culture media are combined in the device during IVC.

Later, the device will be placed in the upper vaginal cavity to enable fertilisation and incubation-like natural conception.

INVO Bioscience CEO Steve Shum said: “This is a momentous day for INVO as the FDA has provided clearance for us to expand our labelling to cover a five-day incubation period for INVOcell.

“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.”