Vitestro
Vitestro has announced that its automated blood drawing device has received CE marking. This acknowledges that the device meets the requirements of the European Medical Device Regulation (MDR) and is now approved for commercial use across the European Union. Vitestro says it is the first company ever to achieve CE marking for an autonomous blood drawing device.
Through a combination of advanced imaging technology and robotics, Vitestro says the device enables hospitals and labs to provide accurate autonomous blood draws, reducing the need for manual handling and improving patient and clinician satisfaction. Vitestro has managed to automate the missing step in total lab automation. This is critical as clinical laboratories are experiencing a severe staffing shortage.
Co-founder and CEO, Toon Overbeeke said: "While this CE marking represents a major step forward for Vitestro, it also marks a transformational moment for healthcare at large. This innovation introduces a completely novel type of medical device, one that allows European hospitals to use autonomous technology to perform invasive medical procedures independently. We believe this technology is foundational, setting a new global standard that will benefit patients and help hospitals prepare for a challenging future."
Several devices have already been ordered by leading European hospitals and clinical laboratories. With the CE marking secured, Vitestro plans a limited market release at these selected hospitals in the next 12 months. Production will be scaled up afterwards, adhering to Vitestro's demonstrated Quality Assurance processes.
Maxine Moor, VP of Commercial Europe said: "Vitestro has been interacting with clinical labs throughout Europe for the past years. They confirmed the huge need for phlebotomy automation and couldn't wait for this innovation! We are eager to start the implementation of our devices in hospitals and laboratories in the coming 12 months. While we will start within the Netherlands and Denmark, we have huge, broader international ambitions. With the CE mark, we are also meeting regulatory demands for the UK market."
