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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

Series B

Vitestro raises $70M Series B to take the Aletta blood-draw robot through De Novo

MedDevice Startups Staff · Mar 10 · 1 min read · Via MedTech Dive

Vitestro closed an oversubscribed $70M Series B on March 10, 2026. New investors include Labcorp Venture Fund, Mayo Clinic, Sutter Health, InterVest, MGFO, PGGM, Puma Venture Capital and ROM Utrecht. Invest-NL, the EIC Fund, Fred Moll, NYBC Ventures and Sonder Capital returned. The Utrecht company named no single lead.

Aletta uses near-infrared imaging, ultrasound and AI to find a vein, insert the needle and fill the tubes without an operator. The device carries a CE mark and is in clinical and pre-commercial use in Europe. It has no US predicate, so Vitestro is preparing a De Novo request. CEO Toon Overbeeke said the round also pays for a next-generation device, manufacturing scale-up and a commercial team. Two health systems and a national lab chain bought in before any US authorization. That is a customer list forming ahead of the regulatory decision.

Questions & Answers

How much did Vitestro raise in its Series B?

Vitestro closed an oversubscribed $70M Series B on March 10, 2026. New investors included Labcorp Venture Fund, Mayo Clinic and Sutter Health; no single lead was named.

What FDA pathway is Vitestro using for the Aletta blood-draw robot?

Vitestro is pursuing FDA's De Novo pathway for Aletta, its autonomous robotic blood collection device, which already holds a CE mark in Europe.

What does the Vitestro Aletta device do?

Aletta uses near-infrared imaging, ultrasound and AI to locate a vein, insert the needle and collect blood samples without an operator.

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