Healeon Announces FDA 510(k) Clearance for Blood Separation and Concentration System

The new technology is used for Platelet Rich Plasma (PRP) preparation. Photo credit: Valeriy_G/iStock/Getty Images Plus

Healeon, a wholly owned subsidiary of Bimini Health Tech, has received FDA 510(k) clearance for Healeon Duet, a new blood separation system for Platelet Rich Plasma (PRP) preparation. Exclusively distributed by Suneva Medical under the trade name Amplifine in the Aesthetic Marketplace, the technology is designed for use within the practitioner’s office and allows operators to safely and quickly separate blood components into customizable platelet concentrations. The Healeon Duet system also enables small blood draw (25ml) into a closed system, and gives operators full control of all of the desired parameters, allowing them to adjust the approach according to application by offering five platelet derived solutions: Low Density PRP (LD PRP), High Density PRP (LD PRP), Leukocyte Rich PRP (LR-PRP), Leukocyte Poor PRP (LP-PRP), and Platelet Rich Fibrin (PRF). "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," says Jeff Greiner, CEO of Healeon and CCO of Bimini Health Tech. "PRP preparation is not a one-size-fits-all for all applications. It's important that the clinician has the appropriate technology to support the proper treatment applications. It's now easier for clinicians to feel confident they are providing their patients the highest quality PRP for each desired treatment application."


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