Devices

FDA Authorizes First Standalone Robotic Device for Blood Draws

FDA has granted Vitestro a de novo authorization for Aletta, the first standalone robotic device designed to draw blood from a patient’s arm without hands-on intervention by a phlebotomist. The device is authorized for use in adults in outpatient settings and must operate under the supervision of a trained phlebotomist. A single phlebotomist can oversee up to three Aletta devices simultaneously, according to the agency.

The agency said the authorization could help address a growing shortage of trained phlebotomists and reduce delays in access to blood collection, one of the most commonly performed medical procedures in the U.S.

The device is designed to perform the blood-draw procedure autonomously after a trained phlebotomist initiates the session and remains available to intervene if necessary, FDA says. It first guides the patient to position their arm, and then it uses near-infrared light and Doppler ultrasound to identify an appropriate vein. If the device cannot identify a suitable vein, it will not attempt to perform the blood draw, it says.

Once the device locates a suitable vein, Aletta autonomously applies a tourniquet, prepares the skin, inserts and disposes of the needle, changes collection tubes and applies a bandage.

Additionally, the device has several safety mechanisms. It continuously applies disinfectant to the skin during the ultrasound scanning process and is cleaned by a trained professional between patients.

If a patient moves excessively during the procedure, the needle automatically detaches and the blood draw stops, FDA notes, adding that onboard sensors can pause the procedure and alert the supervising phlebotomist when potentially unsafe conditions are detected.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome