Vitestro's Aletta Robot Receives FDA Authorization for Blood Draws, Raising Questions About Automation in Care

Key facts

• In August 2026, the FDA authorized Aletta by Vitestro as the first standalone robotic blood-drawing device for outpatient use via the De Novo pathway.
• Vitestro was founded in 2017 by Toon Overbeeke and Brian Joseph and now employs nearly 100 people.
• Aletta received its CE mark for Europe in 2024 and is currently being introduced in clinical settings.
• The device performs the full blood draw, from tourniquet placement to bandaging, using near-infrared light, ultrasound, and Doppler ultrasound.
• Vitestro claims submillimeter needle placement precision and a 94.5% first-stick success rate.
• 82% of patients either preferred Aletta or had no preference, but the sample consisted of volunteers who chose to trial the device.
• One phlebotomist can supervise up to three Aletta devices, potentially easing a global shortage of 5.8 million nurses.
• A nurse from Policlinico hospital in Milan stated that human interaction is a fundamental part of the job and that automation disregards it.