The U.S. Food and Drug Administration (FDA) has authorized Aletta, developed by Vitestro, making it the first autonomous robotic device of its kind capable of drawing blood from a patient’s arm without direct manual intervention while the procedure is being performed. The device is authorized for use with adults in outpatient care settings, with each procedure supervised by an official trained in blood collection.
Under the approved framework, one specialist can supervise up to three Aletta devices at the same time. The FDA believes this model could help address the growing shortage of phlebotomists in the United States, a problem that can delay access to a common diagnostic service.
How does the device perform the blood draw?
A phlebotomist starts each session and remains available to intervene if any problem arises. The device guides the patient to position their arm appropriately, then begins the procedure after the patient or supervisor presses a designated button. Aletta uses near-infrared light and Doppler ultrasound imaging to locate a suitable vein and distinguish it from arteries.
If the device does not find a suitable vein, it does not attempt the draw. Once it identifies the vein, the device performs the remaining steps automatically, including applying the tourniquet, preparing the skin, inserting and disposing of the needle, switching sample-collection tubes, and applying the bandage. After the process is complete, the specialist verifies that the tubes are sufficiently filled and collected in the correct order.
Additional layers of safety
Aletta includes multiple mechanisms to reduce risks during the procedure. It continuously applies antiseptic to the skin during the ultrasound examination, while a trained specialist cleans the device between patients. If the patient moves significantly, the needle automatically disengages and blood collection stops.
Other integrated sensors can also pause the process and alert the supervisor when unsafe conditions are detected. The FDA says adverse events associated with the device were uncommon and mild.
What did the clinical data show?
The authorization was based on clinical data showing that the success rates for blood draws using Aletta were similar to or better than those of trained human specialists when the device began needle insertion. The data included patients with various health conditions, people who reported that accessing suitable veins was difficult for them, and patients with a range of skin tones.
The authorization pathway and what it means in practice
The FDA granted Vitestro marketing authorization through the De Novo pathway, which is intended for new, low- to moderate-risk devices that do not have an existing regulatory classification. At the same time, the agency established special controls related to labeling, performance testing, and clinical testing. These controls, together with general controls, provide reasonable assurance of the device’s safety and effectiveness.
In practice, the authorization does not eliminate the role of phlebotomists but redistributes their tasks: the specialist starts and monitors the session and verifies the samples, while the device performs the blood-drawing steps independently. The expected impact is therefore linked to increased operational capacity at outpatient care sites, while qualified human supervision remains necessary.