# FDA Authorizes First-Ever Standalone Robotic Blood Draw Device Aletta

> fda · REPORTED · 2026-08-19

On August 19, 2026, the FDA authorized Vitestro's Aletta through the De Novo pathway as the first standalone robotic device capable of drawing blood from a patient's arm without hands-on operator intervention, for supervised adult outpatient use. Clinical data showed Aletta achieved blood-draw success rates comparable to or better than trained phlebotomists, with uncommon and mild device-related adverse events.

About Vitestro (Aletta): Vitestro develops autonomous robotic blood collection systems that use near-infrared light, Doppler ultrasound, and AI to locate veins and perform the full blood-draw procedure, serving outpatient clinical settings facing phlebotomist shortages.

- Company: Vitestro (Aletta)
- Sector: medical devices
- Primary source: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.