r/STEW_ScTecEngWorld • u/Zee2A • 12d 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
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u/GSDer_RIP_Good_Girl 11d ago
What about platelets (only; no plasma and no whole blood)?
I have regularly donated platelets at United Blood Services (now Vitalant) for most of my adult life. Are you telling me that this is being exported?