SurGenTec earned FDA 510(k) clearance for its B-Man bone marrow aspirate kit, according to an Aug. 23 news release.
The kit uses a centrifuge-free method for collecting aspirate with minimal contaminants. It has a diamond-tip trocar that works with CELLect filtration technology to reduce bone spicules and other impurities.
"Our aim was to create a minimally invasive solution that simplifies the aspiration process while optimizing cell quality," Travis Greenhalgh, CEO of SurGenTec, said in the release. "The B-MAN Kit preserves native cell structure and facilitates the extraction of healthier cells by reducing the manipulation that takes place, providing physicians with a robust autologous option for patient treatment."