FDA authorizes Vitestro's Aletta robotic blood-draw device for adult outpatient use
The FDA authorized Vitestro’s Aletta, a robotic blood-draw device it says can work without hands-on operator intervention in outpatient care.
The U.S. Food and Drug Administration said it authorized Vitestro’s Aletta, a standalone robotic blood-draw device for adults in outpatient settings, under the supervision of a trained phlebotomy supervisor.
The agency said the decision could affect patients and clinics that face delays because of a shortage of trained phlebotomists. FDA Center for Devices and Radiological Health Director Michelle Tarver said blood draws are among the most commonly performed medical procedures in the United States and that patients may face delays because of a growing shortage of trained phlebotomists.
According to the FDA, Aletta is the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. A trained phlebotomist starts each session and remains available, and one phlebotomist can oversee up to three Aletta devices at the same time, the agency said.
The device guides the patient to position an arm, then the patient or supervisor presses a button to begin. The system uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from arteries. If no appropriate vein is found, the device will not attempt the procedure, the FDA said.
Once a vein is identified, the device applies a tourniquet, prepares the skin, inserts and disposes of the needle, changes collection tubes and places a bandage. The supervising phlebotomist then confirms that the tubes are filled in the correct order and are adequately full.
The FDA said the device includes safety features such as continuous disinfectant during ultrasound scanning, cleaning by a trained professional between patients, automatic needle detachment if a patient moves too much and sensors that can pause the procedure and alert the supervisor if unsafe conditions are detected.
The authorization was based on clinical data, the agency said, showing successful blood-draw rates comparable to or better than trained human phlebotomists when the device proceeds with a stick. The data included patients with varying health statuses, self-reported difficult vein access and varying skin tones. Device-related adverse events were described as uncommon and mild.
The FDA said it granted marketing authorization through the De Novo pathway, which it uses for low- to moderate-risk devices of a new type. The agency said it is setting special controls for labeling, performance testing and clinical testing, along with general controls, to provide a reasonable assurance of safety and effectiveness.
What happens next will depend on how Vitestro and clinical sites use the device under the FDA’s supervision and control requirements. The agency’s authorization allows the device in a limited adult outpatient setting rather than as an unrestricted blood-draw tool.
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