Fernando Borretti
> the needle is not visible to the patient 🤬
Berci Meskó, MD, PhD
Blood draw has always been prone to automation! Now the FDA realizes that too (through the De Novo pathway)! They just authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. "The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time, which may help address the current phlebotomist shortage in the U.S." The authorization is based on clinical data demonstrating efficiency and safety, with device-related adverse events being uncommon and mild. Kudos to Vitestro for making it happen! Source: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device