French medtech startup AVATAR MEDICAL announced that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the US Food and Drug Administration (FDA).

This clearance marks a significant milestone for AVATAR MEDICAL and paves the way for the implementation of its innovative technology in surgical settings.

AVATAR MEDICAL specializes in providing surgeons with a powerful virtual reality tool to enhance their surgical preparations.

The company’s solution creates virtual representations, known as patient avatars, using CT scan or MRI images. Leveraging their proprietary technology developed through four years of research at the prestigious Institut Pasteur and Institut Curie, AVATAR MEDICAL has established a unique expertise in human-data interaction and machine learning.

These patient avatars offer surgeons invaluable insights and assistance during pre-operative planning. By visualizing the patient’s anatomy in a virtual environment, surgeons can gain a deeper understanding of the procedure and optimize their approach. The avatars can also be projected during the actual surgical procedures, serving as a dynamic reference tool for the surgical team.

To date, AVATAR MEDICAL’s VR surgical planning solution has been successfully utilized by over 100 surgeons across 20 different hospitals and universities, including UMass, CUNY, and Columbia University. The technology has proven instrumental in case studies, student education, and patient engagement, leading to the publication of six medical articles that highlight its clinical value and potential impact.

The FDA’s 510(k) clearance underscores the safety and effectiveness of AVATAR MEDICAL’s virtual reality surgical planning solution. This regulatory milestone opens doors for broader adoption of the technology across healthcare institutions, allowing surgeons to harness the power of VR for improved surgical outcomes and patient care.

Xavier Wartelle — AVATAR MEDICAL CEO said: “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.”

AVATAR MEDICAL continues to drive innovation in the field of surgical planning and aims to expand its reach to more medical professionals and institutions worldwide. By combining advanced imaging techniques with immersive virtual reality, the company is revolutionizing the way surgeons prepare for and perform complex procedures, ultimately enhancing the precision and efficiency of surgical interventions.

  AVATAR MEDICAL, US FDA, US Food and Drug Administration, USA, virtual reality, Xavier Wartelle