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FDA Approves First Robotic Blood Draw Device Aletta

Engadget •
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The US Food and Drug Administration has approved Aletta, a standalone robotic device designed to automate blood draws in outpatient settings. The system uses near-infrared light and Doppler ultrasound to identify veins, then performs the entire procedure including applying a tourniquet, inserting and disposing of a needle, and placing a bandage. A trained phlebotomist must initiate the process and supervise the device, but one person can monitor up to three Aletta robots simultaneously.

Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, noted that blood draws are among the most common medical procedures in the United States, yet patient care is often delayed due to a growing shortage of trained phlebotomists. The approval was based on clinical data showing Aletta performs successful blood draws at rates comparable to or better than human phlebotomists.

While Aletta has received FDA clearance, no timeline has been announced for when the device will be available in doctors' offices or other healthcare facilities.