FDA authorizes first standalone robotic device to draw blood

The U.S. Food and Drug Administration has granted marketing authorization to Vitestro for Aletta, the first standalone robotic device capable of drawing blood from a patient's arm. The device is authorized for use in adult outpatients under the oversight of a trained phlebotomist.

Aletta uses near-infrared light and Doppler ultrasound to locate a suitable vein, then autonomously applies a tourniquet, prepares the skin, inserts and disposes of the needle, changes collection tubes, and applies a bandage. One phlebotomist can supervise up to three devices simultaneously, initiating each session and responding to any issues.

After the draw, 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 Aletta achieves successful blood-draw rates comparable to or better than those of 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 reported as uncommon and mild.

Blood draws are among the most commonly performed medical procedures in the United States, and patients may face delays due to a growing shortage of trained phlebotomists, according to Michelle Tarver, M.D., Ph.D., of the FDA Center for Devices and Radiological Health.

The FDA stated that the authorization reflects its commitment to advancing innovative medical devices that help meet critical public health needs while maintaining safety and effectiveness.

Vitestro developed the device to address workflow pressures in clinical settings where phlebotomist availability limits timely sample collection.

The system is intended to augment existing staff rather than replace them, allowing phlebotomists to oversee multiple draws at once.