The FDA has authorized Aletta, from the company Vitestro — the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention.
Cleared on August 19, 2026 through the De Novo pathway (used for new types of low-to-moderate-risk devices), Aletta autonomously locates a suitable vein and performs most of the blood draw, while a trained phlebotomist supervises — and can oversee up to three devices at once. It is authorized for adults in outpatient settings under the oversight of a supervisor trained in phlebotomy.
Built-in safeguards
If a patient moves too much during the procedure, the needle automatically detaches and the draw stops. Onboard sensors can also pause the procedure and alert the supervisor if other unsafe conditions are detected. In FDA-reviewed clinical testing, successful blood-draw rates were comparable to or better than trained human phlebotomists.
Why it matters
Blood draws are among the most common medical procedures, and many health systems face a phlebotomist shortage. By letting one professional supervise several machines, a device like Aletta could help stretch scarce staff — though it is authorized as a supervised tool, not a replacement for trained personnel.