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.
Pulmera designed its platform with a position-sensor-based system that attaches to widely installed surgical C-arms. It captures a series of X-ray images during a brief rotational scan and reconstructs them into a 3D dataset. This enables intraoperative visualization to support clinical evaluation, navigation and surgical decision-making.
The company says it could convert existing infrastructure into a distributed network of mobile 3D imaging systems. This could expand access to advanced intraoperative visualization across orthopedic, spine and related surgical procedures.
Commentary from Pulmera officials
Kevin McGann, Pulmera CEO, said:
“FDA clearance for the CBeam platform is a defining milestone for Pulmera and an important step toward expanding access to advanced intraoperative imaging. 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.”
Dr. Bryan Hartley, co-founder and chief product officer of Pulmera, said;
“As a standalone platform designed to unlock 3D imaging capabilities from existing C-arm infrastructure, CBeam reflects our commitment to practical innovation.”
Dr. Harmeet Bedi, co-founder, added:
“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.
