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Medical Devices / Submissions and Approvals

FDA OKs EmCyte’s Bone Marrow Aspirate System

June 13, 2019

The FDA cleared EmCyte’s PureBMC Supraphysiologic Concentrating System, a device that prepares platelet and cell concentrate from small bone marrow aspirate samples.

The device does not require the bone marrow aspirate sample to be diluted or mixed with whole blood, a method that lessens the sample’s strength and potency.

The concentrating system uses centrifugation to prepare the bone marrow aspirate at the point of care and is designed for minimally invasive collection.

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