FDA Gives Marketing Authorization to Vitestro's Robotic Blood Draw Device

 The Food and Drug Administration granted marketing authorization to Vitestro for Aletta, a robotic blood draw device.

The FDA said the Aletta is the first standalone robotic device that can draw blood from a patient's arm without hands-on operator intervention, autonomously handling each step of the blood draw while a phlebotomist starts each blood draw session and responds to any issues throughout.

The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy, the FDA said.

One phlebotomist can oversee up to three Aletta devices at the same time, which the FDA said could help address a phlebotomist shortage in the U.S.

The FDA said the authorization is based on clinical data showing the Aletta achieves successful blood draw rates comparable to or better than trained human phlebotomists when it proceeds with a stick.

Vitestro is a privately held robotics company based in the Netherlands.

https://www.morningstar.com/news/dow-jones/202608199979/fda-gives-marketing-authorization-to-vitestros-robotic-blood-draw-device