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Last updated: 2026-09-02T07:52:12.304Z

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FDA Approves First Autonomous Robotic System for Blood Draws

Holland & Knight Health Dose · 2026-09-01T00:00:00.000Z

The FDA has authorized the first autonomous robotic system designed for blood draws through the De Novo pathway. This innovative device employs imaging and software to identify suitable veins, perform venipuncture, and collect blood samples, all under the supervision of a clinician. The authorization aims to address existing challenges in a frequently performed medical procedure and mitigate ongoing shortages of trained phlebotomists, potentially improving efficiency and access to care.