FDA approves Aletta robotic blood draw device

The FDA has authorized Vitestro’s Aletta as the first standalone robotic blood draw device for adults in outpatient settings, to operate under the supervision of a trained phlebotomist. The device autonomously carries out the main steps of the blood draw, using near-infrared light and Doppler ultrasound to locate a suitable vein and distinguish it from arteries, then applies a tourniquet, preps the skin, inserts and disposes of the needle, exchanges tubes, and places a bandage. If a suitable vein cannot be identified, the device will not attempt a draw, and safety features include automatic stopping if a patient moves excessively and onboard sensors to ensure safe operation, along with continuous disinfection. A single phlebotomist can supervise up to three Aletta devices at once, which aims to alleviate the current shortage of trained phlebotomists. Clinical data indicate that Aletta achieved blood-draw success rates comparable to or better than trained phlebotomists, with adverse events reported as uncommon and mild. The authorization was granted through the De Novo pathway for a new, low- to moderate-risk device type.