Microbot Medical, a pre-clinical medical device company, said it has taken the first step toward putting its single-use endovascular robotic system on the market in the European Union by engaging with a notified body.
The notified body will audit the Hingham, MA-based company to verify the compliance of its quality management system and the quality of the Liberty robotic surgical system development with widely acceptable standards in the medical device industry. The company said it is also preparing to obtain EU Medical Device Regulation certification to sell the Liberty system throughout the European Union.
“Following the success of multiple pre-clinical studies conducted with the participation of leading European-based interventional radiologists, Microbot is now expanding to seek a wider range of potential users in key growth markets,” said Harel Gadot, Microbot Medical's CEO. “We believe the Liberty Robotic Surgical System has the potential to revolutionize the way catheterization is being done today, by providing a single-use system designed to provide a high degree of stability, as demonstrated in our pre-clinical studies.”
Microbot said its Liberty system is designed to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large capital equipment, while reducing radiation exposure and physician strain.