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RegulationSeptember 1, 2026

How Vitestro’s first-of-its-kind Aletta robot autonomously draws blood

Vitestro received FDA de novo classification in August 2026 for its Aletta robotic phlebotomy system, which autonomously performs blood draws from tourniquet placement through bandaging. The FDA designation recognizes the device as an innovative approach to blood collection addressing a critical public health need.

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