Sira Medical Receives FDA Approval for Augmented Reality Preoperative Surgical Planning Software

Sira Medical has received the U.S. FDA 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 completely obscured on CT scans and MRIs. This 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 greater confidence, reducing patient complications and improving outcomes.

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.

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.

We enable surgeons to manipulate anatomical models, make virtual incisions and simulate corrections, and our proprietary image generation process provides anatomical clarity and fidelity,” said Rick Beberman, co-founder and CEO of Sira Medical.

When planning surgery, surgeons face a recurring challenge in applying radiological information to real patients, and our technology removes this hurdle, improving efficiency and patient safety,” said Dr Jesse Courtier, co-founder of Sira Medical and a paediatric radiologist at the University of California, San Francisco (UCSF).

The $15 billion CT and MRI market is ripe for innovation and we believe Sira Medical is poised to become a leader in medical imaging,” said Kishore Bopardikar, Managing Partner at Eileses Capital.

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