FDA Authorises Aletta for Autonomous Blood Collection

The U.S. Food and Drug Administration (FDA) has authorised Aletta, the first standalone robotic device designed to collect blood from a patient’s arm without hands-on operator intervention. 

The device is intended for adults in outpatient settings and must be supervised by a trained phlebotomist.

Aletta automates key stages of blood collection, potentially helping healthcare providers manage the ongoing shortage of trained phlebotomists in the US. 

One phlebotomist can supervise up to three Aletta devices simultaneously, while remaining available to address any issues during procedures.

The system uses near-infrared light and Doppler ultrasound to identify suitable veins and distinguish them from arteries. 

If an appropriate vein cannot be located, Aletta does not proceed with the blood draw.
Once a suitable vein is identified, the device independently applies a tourniquet, prepares the skin, inserts and disposes of the needle, changes collection tubes and applies a bandage. 

The supervising phlebotomist verifies the collection order and ensures the tubes contain sufficient blood.

Aletta also incorporates several safety measures. Sensors can pause the procedure if unsafe conditions are detected, while excessive patient movement triggers automatic needle detachment and stops the draw. 

The system also applies disinfectant during ultrasound scanning and requires professional cleaning between patients.

The authorisation marks another step towards greater automation in routine clinical procedures while retaining trained professional oversight.