Meet Aletta: The first FDA approved robotic blood draw device

MedTech Meet Aletta: The first FDA approved robotic blood draw device By Ben Adams Aug 20, 2026 9:47am blood test Netherlands MedTech The FDA has approved Vitestro’s Aletta as the first standalone robotic device in the U.S. designed to draw blood without the need for hands-on human help. The approval, the FDA said in a release, will help plug the gap for the ongoing and major shortage of phlebotomists in the U.S.

The robot still requires oversight from a phlebotomist, but one specialist can oversee up to three devices at once, easing pressure on blood draws in an outpatient setting. Aletta performs the entire blood draw on its own, from placing the tourniquet to applying the bandage. To locate a suitable vein, Aletta uses multimodal imaging that combines near infrared and ultrasound.

The device also uses Doppler ultrasound to confirm it has selected a vein and not an artery. In a key trial, the device showed a 94.5% first-stick success rate, with 90% of those in the study seeing pain levels for Aletta less or similar to a manual blood draw. Aletta has been approved in Europe for the past two years.

Back in March, the Netherlands-based medtech nabbed $70 million in an oversubscribed series B round backed by investors including Labcorp Venture Fund, Mayo Clinic, and Sutter Health, among others. That cash will be used for manufacturing scale-up, clinical expansion, and commercialization as the company prepares for broader market adoption in Europe and now entry into the U.S. market.

“This authorization reflects the FDA’s commitment to advancing innovative medical devices that help meet a critical public health need while maintaining the safety and effectiveness patients deserve,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health, in a statement. “Blood draws are one of the most commonly performed medical procedures in the United States, yet patients may face delays due to a growing shortage of trained phlebotomists.” blood test Netherlands MedTech