# FDA De Novo Authorization of Aletta Robotic Blood Draw Device - Sector Highlight: Medical Devices

> fda · REPORTED · 2026-08-19

The FDA authorized Vitestro's Aletta on August 19, 2026 as the first-of-its-kind standalone robotic blood draw device, using near-infrared light, Doppler ultrasound, and AI to locate veins and autonomously handle every step of venous blood collection in adult outpatient settings. One trained phlebotomist can oversee up to three simultaneous Aletta devices, addressing the U.S. phlebotomist shortage.

About Vitestro (Aletta): Vitestro builds autonomous robotic blood collection systems that automate phlebotomy procedures for outpatient clinical settings, reducing dependence on scarce human phlebotomists while maintaining clinical safety.

- Company: Vitestro (Aletta)
- Sector: medical devices
- Primary source: https://www.medtechdive.com/news/vitestro-secures-fda-nod-for-robotic-blood-draw-device/828358/

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