WASHINGTON, D.C. — The Food and Drug Administration last week authorized the first standalone robotic device capable of drawing blood without hands-on operator intervention, allowing a single trained phlebotomist to oversee as many as three machines in adult outpatient settings.
The authorization permits Vitestro to market its Aletta device through the FDA’s De Novo pathway for new medical technologies considered low to moderate risk.
By enabling one supervisor to monitor multiple procedures simultaneously, the system could increase blood-draw capacity and help address shortages of trained phlebotomists, according to the agency.
“Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists,” stated Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health.
A trained phlebotomist must initiate each session and remain available to intervene if problems arise. Patients or supervisors start the procedure after the device guides the patient into the proper arm position.
Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from nearby arteries. If the system cannot identify an appropriate vein, it will not attempt the blood draw.
Once a vein is located, the device independently applies a tourniquet, prepares the skin, inserts the needle, changes collection tubes, disposes of the needle and applies a bandage.
The supervising phlebotomist is responsible for confirming that collection tubes are filled in the correct sequence and verifying that they contain enough blood after the procedure.
The system continuously applies disinfectant during the ultrasound scan, and trained personnel must clean the device between patients.
If a patient moves excessively, the needle automatically detaches and the procedure stops. Additional sensors can pause the process and alert the supervisor when other potentially unsafe conditions arise.
Clinical data reviewed by the FDA showed that when the device proceeded with a needle insertion, successful blood-draw rates were comparable to or better than those achieved by trained human phlebotomists.
The agency reported that the results covered patients with varying health conditions and skin tones, including individuals who described their veins as difficult to access. Device-related adverse events were uncommon and mild.
As part of the authorization, the FDA established special regulatory controls covering labeling, performance testing and clinical testing for this category of device.
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