The US Food and Drug Administration authorized Aletta, the first standalone robotic device capable of collecting blood from a patient’s arm without an operator manually performing the draw.
According to a press release from the US Food and Drug Administration (FDA), Aletta is authorized for adults in outpatient settings under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices simultaneously. A trained phlebotomist initiates each session and remains available to respond to issues throughout the procedure.
Aletta guides the patient in positioning their arm, after which the patient or supervisor initiates the blood draw. The device uses near-infrared light and Doppler ultrasound to identify a suitable vein and distinguish it from arteries. If the device does not identify an appropriate vein, it does not attempt the procedure.
Once Aletta identifies a vein, it performs the remaining steps without operator intervention, including applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and applying a bandage. Following the procedure, the supervising phlebotomist confirms the collection sequence and checks that each tube contains sufficient blood.
During the ultrasound scan, the device continuously applies disinfectant to the skin and is cleaned by a trained professional between patients. If a patient moves excessively during blood collection, the needle automatically detaches and the procedure stops. Additional sensors can pause the procedure and alert the supervisor if other unsafe conditions are detected.
The FDA based its authorization on clinical data showing that among procedures in which Aletta attempted needle insertion, its blood draw success rate was comparable to or better than that of trained phlebotomists. The clinical evaluation included patients with varying health statuses and skin tones, as well as patients who self-reported difficult vein access. Device-related adverse events were uncommon and mild, according to the agency.
The FDA granted Vitestro marketing authorization for Aletta through the De Novo pathway, which is a regulatory pathway for new types of low- to moderate-risk devices. The agency is also establishing special controls addressing labeling, performance testing, and clinical testing.
“Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health.
Source: US Food and Drug Administration
