The CBeam system enables 3D visualization using existing hospital infrastructure during orthopedic and neurological procedures.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Pulmera for its CBeam 3D imaging platform. The technology is designed to “transform existing C-arm infrastructure into scalable intraoperative 3D imaging,” according to a company press release.
The platform uses a position-sensor-based system that attaches to widely installed surgical C-arms. During a rotational scan, CBeam captures X-ray images and reconstructs them into a 3D dataset. This enables intraoperative visualization to support clinical evaluation, navigation, and surgical decision-making.
“FDA clearance for the CBeam platform is a defining milestone for Pulmera and an important step toward expanding access to advanced intraoperative imaging,” says Kevin McGann, CEO of Pulmera, in a release. “We built CBeam to help transform existing C-arm systems into accessible, efficient, and cost-effective 3D imaging solutions for hospitals, ASCs, and surgeons.”
The system is intended for use during orthopedic and neurological surgical procedures. It provides 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 extremities.
“As a standalone platform designed to unlock 3D imaging capabilities from existing C-arm infrastructure, CBeam reflects our commitment to practical innovation,” says Bryan Hartley, MD, co-founder and chief product officer of Pulmera, in a release.
With more than 30,000 active C-arms currently in US hospitals, the company says the platform has the potential to convert existing infrastructure into a mobile 3D imaging network. This expands access to advanced visualization without requiring hospitals to invest in entirely new imaging equipment.
“From the beginning, our mission has been to remove the traditional barriers that have limited access to advanced intraoperative imaging,” says Harmeet Bedi, MD, co-founder of Pulmera, in a release. “FDA clearance is a powerful affirmation of years of innovation, persistence, and belief that surgeons deserve better tools without added complexity.”
Photo credit: Hip view using the CBeam 3D imaging platform
Photo credit: Pulmera
