A robot that takes blood could be the best AI health story of 2026

The FDA granted De Novo clearance to Vitestro’s Aletta robot on 19 August 2026, authorizing it as the first standalone device that draws blood without human needle handling for adult out-patient use under supervision. In the Dutch A.D.O.P.T. trial, Aletta achieved a 95% first-stick success rate, a 0.6% haemolysis rate and 1.3% mild adverse events, meeting or exceeding human phlebotomist benchmarks. The clearance also established special controls permitting future devices to follow the standard 510(k) pathway.