FDA Approves Aletta, a Robotic Device for Automated Blood Draws in Outpatient Settings

Automated Blood Draw Device Receives FDA Approval

The US Food and Drug Administration (FDA) has granted approval for Aletta, a standalone robotic device intended for automated blood draws in outpatient environments. This marks the first-of-its-kind approval for such a device in this setting.

How Aletta Operates

Aletta utilizes near-infrared light and Doppler ultrasound technology to identify suitable veins for blood collection. Once a vein is located, the device automates the subsequent steps of a blood draw, including applying a tourniquet, inserting and disposing of the needle, and placing a bandage on the patient. While the device automates these processes, a trained phlebotomist is required to initiate the procedure and supervise the robot during its operation. A single phlebotomist can oversee up to three Aletta robots simultaneously.

Addressing Phlebotomist Shortages

Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, noted that blood draws are among the most common medical procedures in the United States, and patient delays can occur due to a growing shortage of trained phlebotomists. The FDA's approval of Aletta was based on clinical data demonstrating that the device achieves successful blood draw rates comparable to or exceeding those of a human phlebotomist.

Future Availability

Although Aletta has received FDA approval, there is currently no information available regarding when the device will be deployed in doctors' offices.