The FDA cleared Vitestro’s Aletta as the first standalone robotic blood draw device designed to reduce reliance on hands-on phlebotomy. Aletta performs the blood draw with near-infrared and ultrasound-based vein localization, uses Doppler ultrasound to confirm vein selection, and includes oversight requirements for clinical staff. In a key trial, Aletta reported a 94.5% first-stick success rate and pain outcomes that were comparable to manual draws, with 90% of participants reporting pain levels less or similar. The approval follows Europe clearance and a prior series B financing intended for manufacturing scale-up and clinical expansion. The decision is positioned to address persistent workforce constraints while testing whether automated venipuncture can maintain clinical performance and patient experience.