The FDA has authorized the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention.
The device, Vitestro’s Aletta, is authorized for adults in outpatient settings and must operate under the oversight of a supervisor trained in phlebotomy, according to an Aug. 19 news release. One phlebotomist can oversee up to three Aletta devices simultaneously.
Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from arteries. It can then apply a tourniquet, prepare the skin, insert and dispose of the needle, change collection tubes and apply a bandage without hands-on intervention.
The FDA said clinical data showed Aletta achieved blood draw success rates comparable to or higher than those of trained phlebotomists when it attempted a blood draw. Device-related adverse events were uncommon and mild.
The FDA granted Vitestro marketing authorization through the de novo pathway for low- to moderate-risk devices of a new type.
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