Pulmera CBeam gains FDA clearance for intraoperative 3D imaging
Pulmera’s platform attaches to conventional 2D surgical C-arms and reconstructs rotational X-ray images into 3D datasets for intraoperative visualization.
Pulmera’s CBeam platform has received U.S. FDA 510(k) clearance for intraoperative 3D imaging, according to a company announcement. The system is designed to work with conventional 2D surgical C-arms rather than requiring a separate 3D imaging system.
CBeam uses a position-sensor-based setup that attaches to widely installed surgical C-arms. During a rotational scan, the platform captures a series of X-ray images and reconstructs them into a 3D dataset for intraoperative visualization.
The cleared use covers orthopedic and neurological surgical procedures. Pulmera said the platform is intended for imaging high-contrast objects, bones, joints, maxillofacial anatomy, the cervical, thoracic and lumbar spine, pelvis, acetabulum, and fractures of the upper and lower extremities.
The company is positioning CBeam as a way to extend 3D imaging access through existing C-arm infrastructure. Pulmera cited more than 30,000 active C-arms in U.S. hospitals as the installed base for potential use.
Pulmera’s website describes CBeam as a system for converting existing X-ray C-arms into 3D imaging tools. The company has linked the FDA clearance announcement from its product page.
Companies:Pulmera, U.S. Food and Drug Administration
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Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
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