Sira Medical Wins FDA Clearance for Augmented Reality Preoperative Surgical Planning Software

The company aims to make surgery safer and more efficient

The U.S. Food and Drug Administration granted Sira Medical 510(k) clearance for its augmented reality preoperative surgical planning application, which provides clinicians with advanced imaging to assist in making key patient management decisions.

Parts of the anatomy are often partially or fully hidden on CT scans and MRIs. The lack of clarity forces surgeons to make critical decisions on the fly during surgery, which can lead to errors and inefficiencies. Sira Medical’s holograms remove these obstacles, allowing surgeons to prepare for surgery with more confidence by providing opportunities to reduce patient complications and improve outcomes.

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“We enable surgeons to manipulate anatomical models, make virtual cuts, and simulate corrections, among other features,” said Rick Beberman, Sira Medical’s co-founder and CEO. “Our proprietary image creation process provides anatomical clarity and fidelity.”

To validate its technology, Sira Medical has conducted multiple peer-reviewed studies which demonstrate greater surgical efficiency by reducing operating time, and a preference for using augmented reality models for surgical planning.

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“When planning for surgery, surgeons face a recurring challenge in applying radiology information onto real-world patients, because they still rely on 2D images,” said co-founder and University of California, San Francisco (UCSF) Pediatric Radiologist Dr. Jesse Courtier. “Our technology eliminates that hurdle, thus improving efficiency and patient safety.”

Sira Medical technology was originally developed at UCSF, with funding from the UCSF Innovation Ventures Catalyst program and exclusively licensed through the UCSF Office of Technology Management and Advancement. The company has raised additional funding from 500 Global and Eileses Capital.

“The $15 billion market for CT scans and MRIs is ripe for innovation,” said Kishore Bopardikar, Managing Partner at Eileses Capital. “By achieving this major milestone and attracting positive reviews from surgeons, we believe Sira Medical is poised to become a leader in the medical imaging sector.”

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