What was approved and why it matters
Vitestro's Aletta is the first standalone robot that draws blood from the arm without hands-on operator help, combining imaging, robotics and AI to find a vein and place the needle. The FDA authorized it for adults in outpatient settings, with one trained phlebotomist supervising up to three devices.
Frequently asked questions
When was Aletta authorized?
The FDA granted De Novo authorization to Vitestro's Aletta on 19 August 2026 for blood draws in adults in outpatient settings under the supervision of a phlebotomy trained operator.
What are Aletta's projected US sales?
Zaash Labs' base case is about USD 57 million of US revenue in 2031, within a range of USD 17 million to 126 million. Vitestro has not disclosed a US price, business model or launch date.
How accurate is Aletta?
In the ADOPT trial the robot achieved a 95% first stick success rate, in line with a 93 to 97% manual benchmark, with low haemolysis and only mild adverse events.
Figures are company reported or from published sources unless marked as Zaash Labs estimates. Sources are listed in the executive summary and the full report. Market research to support business decisions; not investment advice.