The U.S. Food and Drug Administration has authorized the Aletta, the first standalone robotic device capable of drawing blood from a patient’s arm without hands-on operator intervention.

According to a news release, the authorization allows the device to be used on adults in outpatient settings under the oversight of a supervisor trained in phlebotomy. A single phlebotomist can oversee as many as three Aletta devices at once, potentially helping address a growing shortage of trained phlebotomists in the United States.

“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,” Michelle Tarver, M.D., Ph.D., director of the FDA’s Center for Devices and Radiological Health, said in teh release. “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.”

Developed by Vitestro, the Aletta autonomously performs each step of the blood collection process after a trained phlebotomist initiates the session. The phlebotomist remains available throughout the procedure to respond if problems arise.

The device first guides the patient to position their arm. The patient or supervising phlebotomist then presses a button to begin the draw. Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from an artery. If the device cannot identify an appropriate vein, it will not attempt the procedure.

Once a suitable vein is located, Aletta performs the rest of the blood draw on its own. The device applies a tourniquet, prepares the skin, inserts and disposes of the needle, changes collection tubes and applies a bandage.

Afterward, the supervising phlebotomist confirms that the collection tubes were filled in the proper order and verifies that each tube contains an adequate amount of blood.

The device incorporates several safety measures. It continuously applies disinfectant to the skin during the ultrasound scan and is cleaned by a trained professional between patients.

If a patient moves excessively during the procedure, the needle automatically detaches and the blood draw stops. Additional onboard sensors can also pause the procedure and alert the supervisor when they detect other potentially unsafe conditions.

The FDA said clinical data showed Aletta achieved successful blood draw rates comparable to or better than those of trained human phlebotomists when the device proceeded with a needle stick. The results included a broad range of patients with varying health statuses, self-reported difficult vein access and different skin tones.

Device-related adverse events were uncommon and mild, according to the FDA.

The authorization supports the agency’s Public Health Pillars of Innovation and Global Leadership, Increasing Access to Affordable Medicines and Medical Products, and Preventing Chronic Disease and Promoting Wellness in America. The FDA said the technology could help patients who increasingly face delays in accessing blood collection, an important diagnostic service.

The FDA granted Vitestro marketing authorization for Aletta through the De Novo pathway, which is used for low- to moderate-risk medical devices that are a new type.

As part of the De Novo authorization, the FDA is establishing special controls covering requirements such as labeling, performance testing and clinical testing. When those special controls are met along with applicable general controls, the agency said they provide a reasonable assurance of the device’s safety and effectiveness.