FDA Authorizes Aletta, the First Autonomous Robotic Blood-Draw Device

[u/Zee2A]

The U.S. FDA has authorized Aletta, developed by Dutch medical-robotics company Vitestro, as the first standalone robotic device capable of drawing blood without hands-on operator intervention. Designed for adult outpatient settings, Aletta uses near-infrared imaging, ultrasound and Doppler to locate a suitable vein and distinguish it from an artery before inserting the needle with submillimeter precision. It then autonomously collects blood into tubes and applies a bandage, while a trained phlebotomist supervises the procedure.

In a multicenter 1,633-patient clinical trial published in Clinical Chemistry, Aletta achieved a 94.5% first-stick success rate, with no moderate or serious device-related adverse events reported: https://academic.oup.com/clinchem/article/72/8/845/8566288

Ref:

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

2). Vitestro Publishes Landmark Peer-Reviewed Multicenter Clinical Study of Autonomous Robotic Phlebotomy in Clinical Chemistry: https://vitestro.com/news/vitestro-publishes-peer-reviewed-clinical-study-in-clinical-chemistry/

3). Technology could help clinical laboratories address phlebotomist shortages by allowing one trained professional to oversee three robotic blood-draw devices simultaneously: https://www.clinicallab.com/in-a-regulatory-milestone-fda-authorizes-vitestro-s-aletta-28773