Vitestro has received authorization from the U.S. Food and Drug Administration (FDA) for its robotic blood drawing device, Aletta. This is the first tool of its kind, according to a release.

The authorization was achieved through the De Novo pathway. Through clinical data, the device proved to successfully draw blood at rates comparable to or better than trained human phlebotomists when it proceeds with a stick.

Aletta draws blood by locating the right vein, utilizing near-infrared light and Doppler ultrasound. It can distinguish between veins and arteries. It also helps patients position their arm while a human phlebotomist oversees the process and aids with any issues. Aletta will not try to draw blood if it can’t find a vein. It will also stop drawing blood if it deems the process unsafe at any time.

To draw blood, the device goes through the same steps a phlebotomist would: applying a tourniquet, preparing the skin, inserting and disposing the needle, changing collection tubes, and placing a bandage. A human phlebotomist confirms that everything was done correctly.

Aletta is authorized to be used in adults in outpatient settings under the supervision of a trained phlebotomist. It is important to note that a single phlebotomist can work up to three Aletta devices at the same time.

Additionally, “the FDA is establishing special controls that define requirements including those related to labeling, performance testing and clinical testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness.”