FDA approves first automated robot for blood draws in doctors' offices
The FDA has approved Aletta, a robotic device capable of independently performing blood draws in outpatient settings, aimed at easing pressure from a shortage of trained phlebotomists.
The US Food and Drug Administration has approved a new type of medical device — a standalone robot called Aletta, designed to perform blood draws from a patient's arm in outpatient settings. It marks the first approval of its kind for this category of automated device.
The robot relies on near-infrared light and Doppler ultrasound to locate a suitable vein, then automatically carries out the remaining steps of the procedure, including applying a tourniquet, inserting and later disposing of the needle, and placing a bandage on the patient's arm.
A trained phlebotomist is still required to begin each procedure and supervise the device while it operates, though a single person can oversee as many as three Aletta units running simultaneously.
Why automation is needed
Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, said blood draws are among the most frequently performed medical procedures in the country, but patients often experience delays because of a worsening shortage of trained phlebotomists.
The approval was based on clinical data showing Aletta achieves successful blood draws at rates comparable to, or better than, those performed by a human phlebotomist.
Despite securing FDA approval, there is currently no timeline for when the device will actually begin appearing in doctors' offices for everyday use.
