Vitestro Timeline

Events

• 2026-08-20 - Regulatory - Vitestro receives FDA De Novo authorization for Aletta - Aletta combines near-infrared, ultrasound and Doppler imaging with robotics and AI to identify veins, guide needle insertion and collect diagnostic samples. The authorization follows Aletta's CE marking and clinical and pre-commercial use in Europe. Vitestro… - source: vitestro.com
• 2026-04-14 - Capability - Vitestro publishes multicenter clinical study of autonomous robotic phlebotomy - The ADOPT study enrolled 1,633 patients across three outpatient phlebotomy departments in the Netherlands, with patient-acceptance data from Mayo Clinic. First-stick success reached 94.5% when a suitable vein was identified; hemolysis was 0.3% and adverse… - source: vitestro.com
• 2026-03-10 - Funding - Vitestro raises $70M Series B to advance autonomous robotic phlebotomy and commercial readiness - Vitestro raised an oversubscribed $70M Series B to support the next generation of Aletta and broader commercial readiness. Proceeds will support U.S. FDA De Novo work, manufacturing scale-up, clinical expansion, and commercial infrastructure development. The… - source: vitestro.com
• 2024-08-28 - Regulatory - Vitestro achieves CE marking for autonomous blood drawing device - Vitestro announced CE marking for its autonomous blood drawing device under the European Medical Device Regulation. The approval cleared the device for commercial use across the European Union. The company said several devices had already been ordered and… - source: vitestro.com
• 2024-05-21 - Commercial Order - Danish hospital pre-orders 3 blood drawing devices in first international deployment for Vitestro - Odense University Hospital signed a pre-order for three Vitestro autonomous blood-drawing devices, marking Vitestro's first international customer commitment. The hospital planned to introduce the systems after CE marking, with pre-deployment workflow… - source: vitestro.com
• 2024-04-30 - Funding - Vitestro secures $22 million (€20 million) for autonomous blood draw device - Vitestro announced a $22 million (€20 million) funding round for its autonomous blood draw device. The raise added capital ahead of CE-marking and broader commercialization. The round sits as the main disclosed funding event before the 2026 Series B. - source: vitestro.com
• 2024-04-03 - Commercial Order - Vitestro secures order from Result Laboratorium for two blood drawing devices - Result Laboratorium ordered two Vitestro autonomous blood-drawing devices for its Dutch diagnostic laboratory network. The devices combine AI-guided ultrasound with submillimetre needle positioning and automate the blood-draw workflow through bandaging.… - source: vitestro.com