Pulmera’s CBeam: The Upgrade That Could Reshape Surgical Imaging

PALO ALTO, CA – June 02, 2026 – In a move that could significantly alter the landscape of surgical technology, medical device company Pulmera today announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its CBeam™ 3D imaging platform. The technology is not another multi-million-dollar machine, but a clever, sensor-based attachment designed to transform the thousands of conventional 2D C-arms already in hospitals into powerful intraoperative 3D imaging systems.

For decades, surgeons have relied on C-arms—mobile X-ray machines—to visualize patient anatomy during procedures. While indispensable, their flat, 2D images often fail to convey the complex, three-dimensional reality of the human body. Pulmera’s CBeam addresses this by capturing a series of X-ray images during a brief rotational scan and reconstructing them into a detailed 3D dataset. This provides surgical teams with a level of intraoperative visualization previously reserved for institutions with the deepest pockets.

“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.”

Breaking the Capital Barrier

The true innovation of CBeam may lie less in its technology and more in its economic model. The current gold standard for intraoperative 3D imaging includes systems like Medtronic's O-arm, a dedicated platform that provides exceptional image quality but comes with a price tag that can exceed $1 million. This level of capital expenditure effectively places advanced 3D imaging out of reach for many smaller hospitals, rural facilities, and Ambulatory Surgical Centers (ASCs).

Pulmera’s strategy sidesteps this financial barrier. By designing CBeam as an upgrade, the company taps into a massive, pre-existing network. According to the company, there are more than 30,000 active 2D C-arms currently installed in U.S. hospitals. CBeam is engineered to convert this existing infrastructure into a distributed web of mobile 3D imaging systems. This approach promises to democratize access, allowing a far broader range of healthcare providers to offer a higher standard of surgical care without the crippling financial burden of new equipment acquisition.

For a hospital administrator at a mid-sized community hospital, the math is compelling. One anonymous department head noted that a new, dedicated 3D imaging system was “simply off the table” for their budget. An upgrade solution, however, could be a justifiable operational expense that dramatically enhances surgical capabilities. This shift from capital-intensive replacement to cost-effective enhancement could unlock advanced care for communities that have historically been underserved by the latest medical technologies.

A New Dimension of Precision in the OR

Beyond the financial implications, the clinical impact of widespread 3D intraoperative imaging is profound. The CBeam platform is cleared for use in orthopedic and neurological procedures, specialties where visualizing complex anatomical structures is paramount. Surgeons performing delicate spinal fusions, repairing complex pelvic fractures, or placing hardware in joints benefit immensely from the ability to see anatomy in three dimensions, in real time.

Conventional 2D imaging requires surgeons to mentally reconstruct a 3D image from multiple flat pictures, a process that is both skill-intensive and inherently imprecise. Intraoperative 3D imaging eliminates this guesswork. It allows surgeons to confirm the precise placement of screws and implants, assess fracture reduction, and navigate sensitive neural and vascular structures with greater confidence. This can lead to improved surgical accuracy, a reduction in revision surgeries caused by malpositioned hardware, and ultimately, better patient outcomes.

“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. This sentiment highlights a core principle of the device: providing sophisticated tools without adding unnecessary complexity to the surgical environment.

From Practical Vision to Regulatory Breakthrough

Pulmera’s journey to FDA clearance is a story of strategic, needs-based innovation. In a market dominated by giants like Medtronic, Siemens Healthineers, and GE Healthcare, who primarily offer integrated, high-cost systems, Pulmera carved out a niche by asking a different question: How can we elevate the tools surgeons already have? The answer was CBeam.

The company’s founders, including physicians, recognized that the primary barrier to broader 3D imaging adoption was not a lack of clinical need, but a lack of financial access. “From the beginning, our mission has been to remove the traditional barriers that have limited access to advanced intraoperative imaging,” added co-founder Harmeet Bedi, MD. “FDA clearance is a powerful affirmation of years of innovation, persistence, and belief that surgeons deserve better tools without added complexity.”

Securing 510(k) clearance is a critical validation. This regulatory pathway requires a company to demonstrate that its device is “substantially equivalent” in safety and effectiveness to a legally marketed predicate device. For an emerging company like Pulmera, clearing this hurdle is the key that unlocks the door to the U.S. market, transforming a promising prototype into a commercial reality.

With this clearance in hand, Pulmera’s focus now shifts to commercialization. The road ahead will involve navigating the complexities of hospital procurement, establishing training protocols for surgeons and staff, and ensuring seamless integration with the myriad models of C-arms in use today. Yet the opportunity is immense. By offering a solution that is both clinically advanced and economically sensible, Pulmera is not just launching a product; it is challenging the industry to think differently about how innovation is delivered. It suggests a future where progress is measured not only by what is new, but by how effectively we can enhance what we already possess.