India, Aug. 20 -- The U.S. Food and Drug Administration has authorized Aletta, the first standalone robotic device that can draw blood from a patient's arm without hands-on operator intervention.
The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current phlebotomist shortage in the U.S.
"This authorization reflects the FDA's commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve," said Michelle Tarver, Director of the FDA's Center for Devices...