Vitestro Receives FDA De Novo Authorization for Aletta®, the World’s First Autonomous Robotic Phlebotomy Device™

Utrecht, the Netherlands, 20 August, 2026 — Vitestro, the pioneer in medical robotics advancing automated diagnostic blood collection, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for Aletta®, its Autonomous Robotic Phlebotomy Device™ (ARPD™). The authorization marks the first U.S. regulatory clearance for a fully autonomous blood draw system and establishes a new device classification for the category.

Read the press release by the FDA here

The Aletta® ARPD™ is designed to autonomously perform diagnostic blood collection. The system combines multimodal imaging, including near-infrared, ultrasound, and Doppler ultrasound to help distinguish between veins and arteries. It combines these capabilities with advanced robotics and artificial intelligence, to identify suitable veins, guide needle insertion, and collect blood samples with high precision and consistency. Aletta® is designed to support phlebotomy departments by performing routine diagnostic blood draws, helping address staffing challenges, standardizing quality, and enhancing the overall patient experience. The device is already CE-marked and in clinical and pre-commercial use across Europe.

“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,” said Toon Overbeeke, CEO and co-founder of Vitestro.

Vitestro will now advance manufacturing scale-up, commercial infrastructure, and phased rollout planning ahead of a U.S. market launch, working alongside our U.S.-based clinical and market research collaborators. As part of this effort and prior to U.S. commercial availability, the company plans a U.S. multicenter clinical trial to validate the performance and safety of Aletta®, generating clinical evidence to support the adoption of automated phlebotomy as a scalable solution for U.S. hospital and outpatient blood draw centers. Aletta will be first commercially deployed in Europe, and the U.S. will follow.

About Vitestro
Vitestro is a global leader in medical robotics advancing diagnostic blood collection through autonomous technology. Headquartered in the Netherlands, the company brings deep expertise in engineering, robotics, artificial intelligence, and commercialization. Vitestro has developed Aletta®, the world’s first and only CE-marked Autonomous Robotic Phlebotomy Device™ (ARPD™), establishing a new category and benchmark for diagnostic blood collection. By integrating advanced robotics, multimodal imaging, and AI, Vitestro is enabling greater precision, operational efficiency, and an improved patient experience in clinical settings. Aletta® is currently CE-marked and being deployed in clinical and pre-commercial settings in Europe and received FDA De Novo authorization in August 2026.

Media Contact
Vitestro
Hannah Oevermans, Senior Marketing & Communication Manager
+31 30 200 4551
publicrelations@vitestro.com