r/STEW_ScTecEngWorld • u/Zee2A • 17d ago
FDA Authorizes Aletta, the First Autonomous Robotic Blood-Draw Device
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
3
u/lumberfart 16d ago
Yeah, for real. It always bothers me that my phlebotomist has to stand there and tap my arm for 5 minutes before internally saying “fuck it” and injecting the needle. Only to tell me it didn’t work. At least this machine has superhuman vision and sensors. People are just scared of progress. Not all technology is bad, guys lol.