The U.S. Food and Drug Administration has authorized Aletta, the first standalone robotic device capable of independently drawing blood from patients. The FDA granted marketing authorization to Vitestro.
The device is authorized for use in adult outpatients under the supervision of a trained phlebotomist. One phlebotomist can oversee up to three Aletta devices simultaneously, initiating each blood-draw session and addressing any issues while the device operates autonomously.
Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein, then independently applies a tourniquet, prepares the skin, inserts and removes the needle, changes collection tubes and applies a bandage. The supervising phlebotomist confirms that collection tubes are filled in the correct order and verifies that all tubes are adequately full.
Clinical data showed that Aletta achieves successful blood-draw rates comparable to or better than trained human phlebotomists, according to the FDA. The trials included a broad range of patients across varying health statuses, including those who self-reported difficult vein access and those with varying skin tones. Device-related adverse events were uncommon and mild.
"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," Michelle Tarver, M.D., Ph.D., from the FDA Center for Devices and Radiological Health, said in a statement.
