Vitestro Receives FDA Authorization for Aletta Autonomous Blood Draw Device

Vitestro has announced that the U.S. Food and Drug Administration (FDA) has officially granted De Novo authorization for Aletta, its Autonomous Robotic Phlebotomy Device (ARPD).

This landmark regulatory clearance represents the very first U.S. approval for a fully autonomous blood collection platform, successfully establishing a new device classification category.

The system integrates multimodal imaging—combining near-infrared, standard ultrasound, and Doppler ultrasound—with advanced robotics and artificial intelligence to identify suitable veins, guide needle placement, and pull samples with accuracy.

Designed for adult patients in outpatient environments, the system operates under a trained supervisor, allowing one technician to simultaneously oversee three active Aletta devices.

Toon Overbeeke, CEO and co-founder of Vitestro, stated:

"From our CE mark in Europe to today's FDA authorization in the U.S., this milestone reflects years of technical development and confirms that autonomous phlebotomy can meet the same rigorous safety and effectiveness standards patients and clinicians expect globally."

Michelle Tarver, M.D., Ph.D., director of the FDA's Center for Devices and Radiological Health, stated:

"This authorization reflects the FDA's commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve. Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists."

After arm placement, Aletta autonomously handles applying tourniquets, preparing skin, inserting needles, swapping tubes, and placing bandages, while safety sensors automatically detach needles if patient movement occurs.

Vitestro will now scale manufacturing and conduct a U.S. multicenter clinical trial prior to commercial availability, following initial deployment across European healthcare systems.