Brainlab Loop-X Mobile Imaging Robot and Cirq Robotic Alignment Module for Spine Both Receive FDA clearance

Opening up new surgical possibilities with robotics

CHICAGO--(BUSINESS WIRE)--Brainlab announced today that the company has reached two major milestones with the FDA clearance for both Loop-X^® Mobile Imaging Robot and Cirq^®​​, a robotic surgical system. Following on CE mark approvals last summer, the FDA clearance paves the way for Brainlab to now enter the US markets with the Cirq robotic alignment module for spine procedures, and Loop-X, the first fully robotic intraoperative imaging device on the market.

The first-of-its-kind, Loop-X works seamlessly with the full Brainlab digital surgery portfolio or with a customer’s existing surgical setup. Independently moving imaging source and detector panels enable flexible patient positioning and non-isocentric imaging which reduces the amount of radiation exposure and increases the variety of indications which can be treated. This mobile imaging robot can be controlled wirelessly with a touchscreen tablet. Loop-X was developed in close collaboration between Brainlab and partner medPhoton based in Salzburg, Austria, where the first Loop-X was installed. Hospital San Juan de Dios León in Spain recently performed the world’s first navigated spine surgery using Loop-X mobile imaging robot technology.

Following on the success and growing install base for Cirq, a universal platform for robotic tasks, the new Cirq Robotic Alignment module is capable of fine tuning the alignment to a pre-planned trajectory and freeing up surgeons’ hands, enabling them to focus on the patient’s anatomy. Surgeons at Royal London Hospital in the United Kingdom have already used Cirq Robotic Alignment for a range of cases from routine lumbar fusions to complex deformity and cervical fractures.

“We’re expanding and diversifying our digital surgery portfolio with robotics across all indications,” said Sean Clark, President, Brainlab, Inc. “Our customers want to offer their patients advanced technologies close to home. Brainlab technologies are designed to enable greater freedom for clinicians and enhance outcomes for patients.”

The recent availability of these robotic medical devices is bringing a futuristic vision of the modern digital operating room closer to reality supporting surgeons in their day-to-day work and bringing benefits to their patients.

About Brainlab

Brainlab is a digital medical technology pioneer founded in 1989 and headquartered in Munich. The company employs more than 1500 people in 20 offices around the globe. Brainlab serves physicians, medical professionals and their patients in over 5600 hospitals in 116 countries.

Brainlab creates software-driven medical solutions that digitize, automate and optimize clinical workflows for neurosurgery, spine, trauma, craniomaxillofacial (CMF), general and vascular surgery as well as radiotherapy and radiosurgery. Core products center around surgical navigation, radiotherapy, digital operating room integration, and information and knowledge exchange. The Brainlab open framework operating system will allow third parties to develop medical applications to further advance the field of spatial computing and mixed reality.

Brainlab is dedicated to creating an impact in healthcare. The company connects opportunities from emerging digital technologies to transform healthcare at scale and help improve the lives of patients worldwide. For more information, please visit Brainlab and follow on LinkedIn, Twitter, Facebook and Instagram.

About medPhoton

medPhoton develops and manufactures robotic imaging solutions for image guided radiation therapy and navigated surgery.