FDA Gives Marketing Authorization to Vitestro's Robotic Blood Draw Device
By Kelly Cloonan
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.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
August 19, 2026 17:57 ET (21:57 GMT)
Copyright (c) 2026 Dow Jones & Company, Inc.The articles, information, and content displayed on this webpage may include materials prepared and provided by third parties. Such third-party content is offered for informational purposes only and is not endorsed, reviewed, or verified by Morningstar.
Morningstar makes no representations or warranties regarding the accuracy, completeness, timeliness, or reliability of any third-party content displayed on this site. The views and opinions expressed in third-party content are those of the respective authors and do not necessarily reflect the views of Morningstar, its affiliates, or employees.
Morningstar is not responsible for any errors, omissions, or delays in this content, nor for any actions taken in reliance thereon. Users are advised to exercise their own judgment and seek independent financial advice before making any decisions based on such content. The third-party providers of this content are not affiliated with Morningstar, and their inclusion on this site does not imply any form of partnership, agency, or endorsement.
Popular
4 Stocks to Buy for the Long-Term While They’re Still Undervalued
Why This Vanguard ETF Is One of the Best
2 Undervalued Stocks to Buy With Long-Term Growth Ahead
The Market May Be Too Pessimistic About This 4-Star Dividend Stock
United States