UTRECHT, Netherlands, Aug. 28, 2024 /PRNewswire/ -- Vitestro, a pioneer in the field of medical robotics, is proud to announce that its innovative automated blood drawing device has received CE marking. This marks a significant milestone for the company, acknowledging 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 is the first company ever to achieve CE marking for an autonomous blood drawing device.
The CE marking underscores the safety, efficacy, and quality of Vitestro's innovative technology, which is set to revolutionize the way blood samples are collected. Through a combination of advanced imaging technology and robotics, 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, expressed his enthusiasm about the achievement: "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 "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."
About Vitestro
Founded in 2017, Vitestro is committed to improving the blood draw experience for patients and clinicians. With its revolutionary autonomous blood draw technology and a team of more than 80 highly skilled specialists in medical robotics, artificial intelligence, imaging software, and healthcare commercialization, Vitestro is transforming the blood draw industry globally. Vitestro is based in Utrecht, The Netherlands.
For more information, visit https://vitestro.com.
Regulatory status
The Vitestro blood draw device received a CE mark in July 2024. It does not have FDA approval and is therefore not available for sale in the US.
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