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One phlebotomist can oversee up to three Aletta units at once, which the FDA says may help address a shortage of trained blood draw technicians
Sarah Silbiger / Getty Images
Vitestro received FDA authorization for Aletta, a standalone robotic device capable of drawing blood from a patient's arm without hands-on operator involvement. The FDA granted the authorization through the De Novo pathway, which applies to low- to moderate-risk devices of a new type.
The Aletta is approved for use with adults in outpatient settings and must operate under the oversight of a phlebotomy-trained supervisor. A single phlebotomist can monitor up to three devices simultaneously, which the FDA said may help address the current shortage of trained phlebotomists in the United States.
