Silver Spring, Maryland, August 19, 2026
The U.S. Food and Drug Administration (FDA) has authorized Aletta, a first-of-its-kind standalone robotic device designed to perform blood draws from a patient’s arm without hands-on operator intervention. Developed by Vitestro, the device is authorized for use in adults in outpatient settings under the supervision of a trained phlebotomist. The authorization represents a significant milestone in medical device innovation and automated blood collection, while potentially helping healthcare providers address the growing shortage of trained phlebotomists in the United States. One trained phlebotomist can oversee up to three Aletta devices simultaneously, creating the potential to increase blood-collection capacity while maintaining clinical supervision and patient-safety controls.
Robotic System Automates Blood Collection
Aletta autonomously performs multiple steps of the blood-draw procedure after a trained phlebotomist initiates each session. The patient first positions their arm with guidance from the device, after which the patient or supervising professional activates the system. Aletta then uses a combination of near-infrared light and Doppler ultrasound to identify an appropriate vein and distinguish it from arteries. If the system cannot identify a suitable vein, it does not proceed with the needle insertion. Once an appropriate vein has been located, Aletta independently performs the subsequent stages of the procedure, including applying a tourniquet, preparing the skin, inserting and disposing of the needle, changing collection tubes, and applying a bandage. The supervising phlebotomist remains available throughout the procedure and confirms that collection tubes are filled in the appropriate sequence and adequately filled. This combination of robotic automation and trained human oversight is designed to support efficient blood collection without removing professional supervision from the clinical workflow.
Multiple Safety Features Support Clinical Use
The FDA authorization incorporates a number of patient-safety mechanisms designed to reduce procedural risks. During ultrasound scanning, the device continuously applies disinfectant to the skin, while trained personnel clean the system between patients. Aletta also incorporates sensors capable of detecting potentially unsafe conditions. If a patient moves excessively during the procedure, the needle automatically detaches and the blood draw stops. Additional onboard sensors can pause the procedure and alert the supervising phlebotomist when other unsafe conditions are detected. These features are intended to provide multiple layers of protection while allowing the robotic system to perform routine procedural steps. According to the FDA, clinical data demonstrated that Aletta achieved successful blood-draw rates comparable to or better than trained human phlebotomists when the device proceeded with a needle stick. The clinical evaluation included patients with different health statuses, individuals who reported difficult vein access, and patients with varying skin tones. Device-related adverse events were reported as uncommon and mild, supporting the agency’s assessment of the technology.
Advertisement
De Novo Authorization Establishes Regulatory Controls
The FDA granted Vitestro marketing authorization for Aletta through the De Novo pathway, which is used for certain novel medical devices that present low-to-moderate risks and do not have an existing substantially equivalent predicate device. Alongside the authorization, the FDA is establishing special controls covering areas such as labeling, performance testing, and clinical testing. Together with general medical-device controls, these requirements are intended to provide reasonable assurance of the device’s safety and effectiveness. The authorization also supports broader FDA priorities around medical-device innovation, healthcare access, and public health. Blood collection is one of the most frequently performed medical procedures in the United States, yet healthcare systems are increasingly challenged by shortages of trained phlebotomy professionals. By enabling one qualified phlebotomist to supervise multiple devices, Aletta could provide a new model for outpatient blood collection and help healthcare organizations expand access to diagnostic testing. The authorization therefore marks an important development in robotic healthcare technology, automated diagnostics, and regulated medical-device innovation, demonstrating how advanced sensing, robotics, and clinical oversight can be combined to address practical challenges in healthcare delivery.
Source: FDA press relese
