The US Food and Drug Administration (FDA) has authorized Aletta, a standalone robotic device developed by Vitestro that can draw blood from a patient’s arm without hands-on operator intervention. The device is authorised for use in adults in outpatient settings and must operate under the supervision of a trained phlebotomist.

The authorisation comes as the US faces a growing shortage of trained phlebotomists, potentially contributing to delays in accessing blood-drawing services. Under the authorised operating model, a single phlebotomist can supervise up to three Aletta devices simultaneously.

Aletta is designed to autonomously perform the key steps involved in a blood draw. A trained phlebotomist initiates each session and remains available to intervene if required. The patient is guided to position their arm, after which the patient or supervisor activates the device.

The system uses near-infrared light and Doppler ultrasound to identify a suitable vein and distinguish it from arteries. If an appropriate vein cannot be identified, Aletta does not proceed with the procedure.

Once a suitable vein is located, the robotic system performs the subsequent blood-collection steps, including applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes and applying a bandage. The supervising phlebotomist verifies that the collection tubes are filled in the appropriate sequence and adequately filled after the procedure.

Patient safety is incorporated through multiple monitoring and control features. Aletta continuously applies disinfectant to the skin during the ultrasound scanning process, while trained personnel clean the device between patients. If a patient moves excessively during the procedure, the needle automatically detaches and the blood draw is stopped. Additional onboard sensors can also pause the procedure and alert the supervisor when potentially unsafe conditions are detected.

According to the FDA, clinical data supporting the authorization showed that Aletta achieved successful blood-draw rates comparable to or better than those of trained human phlebotomists when the device proceeded with needle insertion. The performance was evaluated across a broad patient population, including individuals with different health conditions, people who reported difficult vein access and patients with varying skin tones. Device-related adverse events were reported as uncommon and generally mild.

The FDA granted marketing authorization to Vitestro for Aletta through the De Novo pathway, which is used for novel medical devices considered to pose low to moderate risk. Alongside the authorisation, the FDA has established special controls covering areas such as labelling, performance testing and clinical testing.

The agency said that when these special controls are met together with applicable general controls, they provide reasonable assurance of the device’s safety and effectiveness.

The authorisation represents a step towards greater use of robotics and automation in routine clinical procedures, with the potential to expand access to blood collection services while allowing trained healthcare professionals to supervise multiple devices.