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FDA approval
Sira Medical receives FDA clearance for AR surgical planning application
Extended Reality
Feb 21, 2024
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Extended Reality

Extended Reality

Feb 21, 2024

Sira Medical receives FDA clearance for AR surgical planning application

FDA approval

  • Sira Medical has been given the green light by the US Food and Drug Administration (FDA) for the rollout of its new service, an AR preoperative surgical planning application.

  • The service aids clinicians by providing higher-quality imaging, which can be vital for making patient management decisions. The company points to several benefits of this application based on peer-reviewed studies, which include time saved during operations and a preference for AR models in surgical planning. 

  • Sira Medical offers AR software for medical imaging, which is applicable for clinicians, patients, and students to visualize human anatomy. Its platform can be accessed via Microsoft’s HoloLens headset or a smartphone. Apart from surgical planning, the models on the platform can be used to complement existing curricula for academia. 

  • Analyst QuickTake: The FDA approval follows the company’s invitation to NVIDIA’s Inception Program in March 2020, which sought to incorporate machine-learning capabilities for surgical planning. Further, studies indicate that Sira Medical’s platform is as accurate as a standard CT scan. 

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