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Medical Devices / Submissions and Approvals

Centerline Biomedical’s Surgical Positioning System Gets FDA Clearance

July 11, 2019

The FDA granted 5210(k) clearance to Centerline Biomedical’s Intra-Operative Positioning System (IOPS), a device used in endovascular procedures to provide 3D visualization.

The non-radiation-based surgical navigation system uses anatomical mapping algorithms and electromagnetic tracking to give surgeons 3D color visualization and guidance during procedures.

The holographic system offers an alternative to X-ray fluoroscopy, which exposes surgeons and operating room staff to potentially dangerous radiation.

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