Pulmera Announces FDA 510(k) Clearance for CBeam™ 3D Imaging Platform

Pulmera has announced that it has received U.S. Food and Drug Administration 510(k) clearance for its CBeam™ 3D imaging platform.

CBeam is designed to transform conventional 2D surgical C-arms into intraoperative 3D imaging systems, helping surgical teams visualize complex anatomy during procedures while enabling hospitals to expand access using imaging infrastructure they already own.

CBeam is intended to provide 3D medical imaging during orthopedic and neurological surgical procedures where clinicians benefit from 3D visualization of complex anatomical structures, including high-contrast objects, bones, joints, maxillofacial anatomy, the cervical, thoracic and lumbar spine, pelvis, acetabulum, and fractures of the upper and lower extremities.

The platform uses a position-sensor-based system that attaches to widely installed surgical C-arms. During a brief rotational scan, CBeam captures a series of X-ray images and reconstructs them into a 3D dataset, enabling intraoperative visualization to support clinical evaluation, navigation, and surgical decision-making.

With more than 30,000 active C-arms currently in U.S. hospitals, CBeam has the potential to convert existing infrastructure into a distributed network of mobile 3D imaging systems, expanding access to advanced intraoperative visualization across orthopedic, spine, and related surgical procedures.

“FDA clearance for the CBeam platform is a defining milestone for Pulmera and an important step toward expanding access to advanced intraoperative imaging,” said Kevin McGann, CEO of Pulmera. “We built CBeam to help transform existing C-arm systems into accessible, efficient, and cost-effective 3D imaging solutions for hospitals, ASCs, and surgeons. This achievement validates our vision to bring advanced imaging directly into the operating room without requiring hospitals to invest in entirely new imaging infrastructure.”

“As a standalone platform designed to unlock 3D imaging capabilities from existing C-arm infrastructure, CBeam reflects our commitment to practical innovation,” said Bryan Hartley, MD, co-founder and Chief Product Officer of Pulmera.

“From the beginning, our mission has been to remove the traditional barriers that have limited access to advanced intraoperative imaging. FDA clearance is a powerful affirmation of years of innovation, persistence, and belief that surgeons deserve better tools without added complexity” added co-founder Harmeet Bedi, MD.

Source: Pulmera

The post Pulmera Announces FDA 510(k) Clearance for CBeam™ 3D Imaging Platform appeared first on Surgical Robotics Technology.