THURSDAY, Aug. 20, 2026 (HealthDay News) -- The U.S. Food and Drug Administration has authorized the Aletta as the first standalone robotic device that can draw blood from a patient's arm.
The device is authorized for use in adult outpatients with the oversight of a trained phlebotomist. One phlebotomist can oversee up to three Aletta devices simultaneously, initiating each session and responding to any issues, while the Aletta autonomously handles each step of the blood draw. The device uses near-infrared light and Doppler ultrasound to locate a suitable vein and then proceeds through the remaining steps on its own: applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and applying a bandage. Afterward, the supervising phlebotomist confirms that collection tubes are filled in the correct order and verifies that all tubes are adequately full.
The authorization is based on clinical data showing that the Aletta device achieves successful blood draw rates comparable to or better than trained human phlebotomists. Trials included a broad range of patients across varying health statuses, including those who self-reported having difficult vein access and those with varying skin tones. Device-related adverse events were uncommon and mild.
"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., from the FDA Center for Devices and Radiological Health, said in a statement. "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."
Marketing authorization for the Aletta device was granted to Vitestro.
