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Avatar Medical, a spin-off of Institut Curie, receives FDA clearance for its innovative medical imaging solution

22/05/2026

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Avatar Medical, spin-off de l’Institut Curie, reçoit l'agrément de la FDA pour sa solution innovante d’imagerie médicale

AVATAR MEDICAL, a company born out of research conducted at Institut Curie and Institut Pasteur, has just reached a decisive milestone by obtaining authorization from the Food and Drug Administration (FDA) for "Avatar Medical Vision." This 3D medical imaging software platform streamlines communication between doctors and patients while optimizing preoperative planning and the accuracy of surgical interventions. This certification will enable the company to market its solution in the United States, to the benefit of patients.

"Since its inception in 2020, AVATAR MEDICAL has come an impressive way! Obtaining this FDA certification demonstrates that startups born out of, and supported by, Institut Curie are capable of transforming academic research into tangible products that are now authorized for the U.S. market. This will make it possible to improve the care of many patients. It is a source of great pride!"

Cécile Campagne Director of Institut Curie’s Technology Transfer Office and Deputy Director of Carnot Curie Cancer

Stemming from four years of research in human-data interaction and machine learning conducted at Institut Curie and Institut Pasteur, Avatar Medical is developing "Avatar Medical Vision," a software platform for the instant processing of medical images with 3D rendering. It is the first software approved for a 3D medical display technology without glasses, offering a shared visualization between doctors and patients while preserving the depth perception necessary to understand complex anatomies.
After obtaining the CE marking in 2025 for "Avatar Medical Vision", the MedTech takes a new decisive step in its international expansion with the 510(k) authorization1 from the Food and Drug Administration (FDA). This major validation now allows Avatar Medical to commercialize its advanced technology in the United States, making this technology accessible to American surgeons and patients.

Designed for highly imaging-dependent specialties such as neurosurgery, ENT, orthopedics, oncology, and interventional radiology, the platform will offer clinicians the opportunity to work directly with the specific anatomy of the patient in three dimensions. The key: better collaboration between practitioners, optimized preparation of interventions, and valuable assistance to medical teams during surgery.
 

"For too long, doctors have made three-dimensional decisions from two-dimensional images," explains Xavier Wartelle, CEO of Avatar Medical. "At Avatar Medical, we have made deliberate technological choices to change this, prioritizing glasses-free shared visualization so that doctors and patients can view anatomy together. When this happens, the conversation becomes clearer, more natural and, ultimately, more productive."

Read the AVATAR MEDICAL press release

 

Read more informations about Avatar Medical

[1]A manufacturer placing a device of any class on the market must demonstrate that the device is substantially equivalent to a legally marketed device to which a class has already been assigned. The way to do it is to submit a Premarket Notification to the FDA, commonly referred to as a 510(k) notice.