AVATAR MEDICAL Receives FDA Clearance For its Virtual Reality Surgical Planning Solution

Medtech startup AVATAR MEDICAL announced today that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

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火曜日, 6月 6, 2023
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FDA, Health Technology, Telemedicine, Virtual Medicine, Data Management, Technology, Radiology, Surgery, Apps, Applications, Biometrics, Medical Devices, Wearables, Mobile Technology, Other Technology, Biotechnology, Software, Health, Columbia University, CT, CUNY, Surgeon, Education, Kidney cancer, University, Multimedia, Research, Nephrectomy, Associate, VR, AVATAR, MRI, Interventional radiology, Hospital, Patient, Machine learning, Institut Pasteur de Dalat, Virtual reality, XR, Regulation of tobacco by the U.S. Food and Drug Administration, Pasteur Institute, Food, Medical imaging, University of Massachusetts, Medtech
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EUROPE, UNITED STATES, NORTH AMERICA, FRANCE, CALIFORNIA
概要
Key Points: 
  • Medtech startup AVATAR MEDICAL announced today that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
  • (Photo: Business Wire)
    AVATAR MEDICAL helps surgeons better prepare their procedures through the use of virtual reality (VR) representations of their patients.
  • They serve as valuable tools for pre-operative planning and can also be displayed during surgical procedures.
  • We expect European medical device certification for next year”, says Xavier Wartelle, CEO of AVATAR MEDICAL.


Medtech startup AVATAR MEDICAL announced today that its virtual reality (VR) surgical planning solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230606005124/en/

Surgeon visualizing a kidney cancer CTScan to plan his partial nephrectomy. (Photo: Business Wire)

Surgeon visualizing a kidney cancer CTScan to plan his partial nephrectomy. (Photo: Business Wire)

AVATAR MEDICAL helps surgeons better prepare their procedures through the use of virtual reality (VR) representations of their patients. These patient avatars are generated instantly from CT scan or MRI images with an underlying proprietary technology based on four years of research in human-data interaction and machine learning conducted at the Institut Pasteur and Institut Curie. They serve as valuable tools for pre-operative planning and can also be displayed during surgical procedures.

More than 100 surgeons from 20 different hospitals and universities, including UMass, CUNY and Columbia University, have benefited from the solution. To date, it has been used for case studies, student education and patient engagement, leading to 6 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.” Says Venkatesh Krishnasamy MD, Interventional Radiology, Associate Professor of Radiology, Columbia University

“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”, says Xavier Wartelle, CEO of AVATAR MEDICAL.

About AVATAR MEDICAL

AVATAR MEDICAL is an innovative spin-off from the Institut Pasteur and Institut Curie. AVATAR MEDICAL was incorporated in Paris, France in July 2020 by an experienced team of French and American co-founders. It has an American subsidiary in Mountain View, California. Since its inception, the company has been recognized by prestigious competitions and programs including: Medtech Innovator, EIC Accelerator, Bpifrance i-Lab and i-Nov, the MedFIT award for the most innovative European startup, the Laval Virtual 2022 Grand Prix and the NVIDIA Inception program.

https://avatarmedical.ai/

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