News & Trends - MedTech & Diagnostics
Australia takes global lead with latest robotic-assisted knee replacement technology

MedTech & Diagnostics News: In a milestone for orthopaedic surgery, the Australian Institute of Robotic Orthopaedics (AIRO) has been granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its high-speed Intelligent Laser Osteotomy (HAiLO™) system in knee replacement procedures.
The HAiLO system represents a pioneering fusion of non-contact laser energy, surgical robotics, and real-time intraoperative digital sensing. This integration empowers orthopaedic surgeons with unprecedented precision, enabling them to achieve sub-millimetre accuracy in both full and partial knee replacement surgeries.
AIRO’s co-founder and CEO, Associate Professor Brett Robertson, underscored the system’s capacity to tailor surgical solutions to the unique needs of individual patients.
“Receiving the Breakthrough Device Designation from the FDA validates the innovative nature of our technology, its commercial potential, and, most importantly, its significant potential benefits to patients worldwide,” Professor Robertson remarked.
Professor Riaz Khan, Orthopaedic Surgeon and AIRO Chairman, echoed Associate Professor Robertson’s sentiments, emphasising the impact of the HAiLO system on orthopaedic surgery.
“The HAiLO system will change the practice of orthopaedics as we know it today,” Professor Khan declared. He elaborated on the system’s transformative capabilities, particularly its real-time digital mapping and non-contact laser bone shaping features, envisioning a future where knee replacement surgery results in near-normal joint function, akin to a ‘forgotten knee.’
With over 1.4 million knee replacement surgeries performed globally each year, the HAiLO system aims to address the dissatisfaction often experienced by patients with traditional methods. By mitigating misalignment, thermal and mechanical bone damage, and preserving crucial ligaments, AIRO’s innovative approach sets a new standard in orthopaedic care.
“Our vision at AIRO is to restore vitality and movement to the world,” Professor Robertson reiterated, highlighting the company’s commitment to enhancing the lives of millions through next-generation implants. “In doing so,” he concluded, “we aim to raise global standards in orthopaedic care.”
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