FDA OKs Avatar Medical’s VR Surgical Planning Tool

Startup Avatar Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its virtual reality (VR) surgical planning solution.
 
The company aims to help surgeons better prepare for procedures using VR representation of their patients. The patient avatars are generated from CT scans or MRI images with a proprietary technology based on four years of research on human-data interaction and machine learning conducted at the Institut Pasteur and Institut Curie. They can be valuable tools for pre-op planning and can be displayed during surgical procedures.
 
Over 100 surgeons from 20 different hospitals and universities have used the VR solution. To date, it’s been used for case studies, student education, and patient engagement, which has led to six medical publications.
 
“Avatar Medical is a unique hardware agnostic XR software platform. With the ability to plan based on preoperative imaging and then evaluate as well as confirm based on intraoperative imaging, I now have an additional level of capability and confidence in my advanced percutaneous and endovascular interventions.” Venkatesh Krishnasamy MD, Interventional Radiology, Associate Professor of Radiology, Columbia University, told the press.
 
“After receiving tremendous positive feedback from surgeons over the past 3 years, the FDA’s clearance is a major milestone in getting our VR solution in their hands to care for their patients. We expect European medical device certification for next year,” added Xavier Wartelle, CEO of Avatar Medical.
 
The company was incorporated in Paris, France in July 2020 by a team of French and American co-founders and has a subsidiary in Mountain View, Calif.