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- FDA authorizes Aletta, first standalone robotic device for automated blood drawsThe U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
- FDA releases discussion paper seeking input on regulation of generative AI medical devicesThe U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…