WASHINGTON (WDNews) — The U.S. Food and Drug Administration has authorized the first standalone robotic device capable of drawing blood from a patient’s arm without hands-on help from an operator.
According to the FDA, the device, called Aletta, is authorized for adults in outpatient settings and must operate under the supervision of a trained phlebotomist. One phlebotomist can oversee up to three Aletta devices at the same time.
“This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “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.”
According to the FDA, a trained phlebotomist starts each session and remains available if a problem occurs. The patient positions their arm before the patient or supervisor presses a button to begin the blood draw.
The Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from arteries. If the device cannot find an appropriate vein, it will not attempt to insert the needle.
Once a vein is found, the device can complete the remaining steps on its own. That includes applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes and placing a bandage.
The supervising phlebotomist then confirms the collection tubes were filled in the correct order and contain enough blood.
The FDA said the Aletta also includes several safety features. If a patient moves too much during the procedure, the needle automatically detaches and the blood draw stops. Other sensors can pause the procedure and alert the supervisor if potentially unsafe conditions are detected.
According to the FDA, clinical data showed the Aletta achieved successful blood draw rates comparable to or better than trained human phlebotomists when the device proceeded with a needle stick. Testing included patients with different health conditions and skin tones, as well as people who reported having difficult-to-access veins.
Device-related adverse events were uncommon and mild, according to the FDA.
The FDA granted marketing authorization for the Aletta to Vitestro through the agency’s De Novo pathway, which is used for new types of low- to moderate-risk medical devices.
