Home » FDA Clears Healeon’s Blood-Separation Device
FDA Clears Healeon’s Blood-Separation Device
Devices Submissions and Approvals
Healeon has obtained FDA 510(k) clearance for Healeon Duet, a blood-separation system used in the preparation of plasma.
The device is cleared for Platelet Rich Plasma preparation, enabling quick separation of blood components into customizable platelet concentrations. The Duet can be used in a healthcare practitioner’s office.
"The Healeon Duet overcomes one of the most challenging parts of platelet preparation – customizing concentration levels in controlled dosages for specific procedure types in a single platform," said Healeon CEO Jeff Greiner.