The U.S. Food and Drug Administration has authorised Aletta as the first autonomous robotic device capable of drawing blood from a patient's arm. The marketing authorisation was granted to Vitestro.
The device is authorised for use in adult outpatient patients under the supervision of a trained phlebotomist. One phlebotomist can supervise up to three Aletta devices simultaneously, initiating each session and responding to any issues, while Aletta independently manages each step of the blood draw.
The device uses near-infrared light and Doppler ultrasound to locate a suitable vein and then proceeds autonomously with the remaining steps: applying a tourniquet, preparing the skin, inserting and discarding the needle, changing collection tubes and applying a bandage. Subsequently, the supervising phlebotomist confirms that the collection tubes have been filled in the correct order and verifies that all tubes are sufficiently full.
The authorisation is based on clinical data demonstrating that the Aletta device achieves blood draw success rates comparable to or better than those of trained human phlebotomists. The trials included a wide range of patients with different health conditions, including those who reported difficult venous access and people with different skin tones. Adverse events related to the device were uncommon and mild.
"This authorisation reflects the FDA's commitment to advancing innovative medical devices that help address a critical public health need whilst maintaining the safety and effectiveness that patients deserve," said Michelle Tarver, M.D., Ph.D., of the FDA's Centre for Devices and Radiological Health, in a statement. Blood draws are among the most frequently performed medical procedures in the United States, though patients may face delays due to a growing shortage of trained phlebotomists.
