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FDA approval
OnPoint Surgical receives 510(k) FDA clearance for AR spine system
Extended Reality
Sep 11, 2023
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Extended Reality

Extended Reality

Sep 11, 2023

OnPoint Surgical receives 510(k) FDA clearance for AR spine system

FDA approval

  • MedTech company OnPoint Surgical, specializing in AR and AI tech for various medical procedures, has received clearance from the US Food and Drug Administration (FDA) for its OnPoint AR Spine System.

  • The company’s OnPoint AR spine system is compatible with major implant manufacturers and doesn't necessitate changes in surgical techniques. Further, the company claims that its system is cost-effective and offers a more precise alternative to current robotic systems. 

  • OnPoint Surgical specializes in AR guidance for surgical spinal procedures, including minimally invasive, robotic, implant, and non-implant surgery. The company’s platform superimposes virtual surgical guides and virtual spinal implants onto the surgeon’s visual field using see-through optical head-mounted displays. Additionally, its tech is applicable to hospitals and ambulatory surgery centers. 

  • Analyst QuickTake: Other XR MedTech firms that have received FDA clearance over the past year include MediView, which received clearance for its AR surgical navigation platform in July 2023 , and German-based apoQlar, for its MR software platform, VSI HoloMedicine in December 2022 .

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