Pulmera wins FDA clearance for 3D imaging platform

Pulmera announced today that it received FDA 510(k) clearance for its CBeam 3D intraoperative imaging platform.

Palo Alto, California-based Pulmera designed CBeam to transform conventional 2D surgical C-arms into intraoperative 3D imaging systems. The technology helps surgical teams visualize complex anatomy during procedures. It enables hospitals to expand access using imaging infrastructure they already own.

The company said it aims for CBeam to provide 3D imaging during orthopedic and neurological surgical procedures. These are procedures in which clinicians benefit from 3D visualization of anatomical structures. Those include high-contrast objects, bones, joints, maxillofacial anatomy, the cervical, thoracic and lumbar spine, pelvis, acetabulum. It also extends to fractures of the upper and lower extremities.

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