Aletta Robotic Phlebotomy

The US Food and Drug Administration (FDA) authorized the first stand-alone robotic blood draw device for use in adults in an outpatient setting.

The Aletta device draws blood from a patient’s arm without the need for a hands-on operator. The device must be used with the oversight of a trained phlebotomist, but 1 person can oversee up to 3 devices at a time.

After the supervisor presses a button to begin the blood draw, the device uses near-infrared light and Doppler ultrasound to locate a suitable vein and handles the remaining steps of the blood draw. It applies a tourniquet, sterilizes the skin, inserts and disposes of the needle, changes the collection tubes, and places a bandage. According to the FDA press release, if the device cannot find an appropriate vein, it will not attempt to draw blood, and if a patient moves too much, the needle will automatically detach. Additional sensors in the device are designed to pause the procedure and alert the supervisor if conditions are unsafe.

The approval is based on clinical findings that the device successfully draws blood at rates comparable to or better than human phlebotomists. According to the FDA, adverse events related to the device were uncommon and mild.

References

JAMA, September 4, 2026. doi:10.1001/jama.2026.12070

FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device, August 19, 2026, https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device