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FDA clears first robotic blood draw device via De Novo pathway

A blurry photo of a male doctor in the background and a blood sample in a test tube in the foreground.
Photo: Christopher Furlong/Getty Images

The US Food and Drug Administration has granted clearance to Vitestro’s Aletta device, easing phlebotomist shortages.

Using near‑infrared light and Doppler ultrasound to locate veins, Aletta, which is manufactured by the Dutch device company Vitestro, aims to ease phlebotomist shortages by allowing one clinician to oversee multiple units. Approval came through the FDA’s De Novo pathway, reserved for novel, low‑ to moderate‑risk devices

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