Autonomous blood drawing device receives CE marking
Vitestro, a Dutch medical robotics firm, has announced that its autonomous blood drawing device has received CE marking, making it the first such device to be approved for commercial use in the European Union. This milestone, achieved in July 2024, signifies the device’s compliance with the European Medical Device Regulation (MDR) standards for safety and efficacy.
The device combines advanced imaging technology with robotics to perform autonomous blood draws, potentially alleviating the growing staffing shortages in clinical laboratories. Toon Overbeeke, co-founder and CEO of Vitestro, said: “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.”
Implementation plans
Vitestro plans a limited market release at selected European hospitals and clinical laboratories over the next 12 months. Several leading institutions have already placed orders for the device. Maxine Moor, VP of Commercial Europe, explained: “We are eager to start the implementation of our devices in hospitals and laboratories across Europe in the coming 12 months. While we will start within the Netherlands and Denmark, we have huge, broader international ambitions.”
Implications for healthcare
The autonomous blood drawing device is positioned as a solution to automate the final step in total lab automation. This development could significantly impact healthcare delivery, particularly in light of the severe staffing shortages faced by clinical laboratories.
While the device has achieved CE marking, it has not yet received FDA approval and is therefore not available for sale in the United States. Vitestro, founded in 2017 and based in Utrecht, employs over 80 specialists in fields including medical robotics, artificial intelligence, imaging software, and healthcare commercialisation.
- For more information, visit: https://vitestro.com/
