Point Robotics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its minimally invasive surgical robot, the POINT kinguide robotic-assisted surgical system.
This premarket notification marks both Taiwan’s very first FDA-cleared surgical robot and the first ever handheld robot framework equipped with a parallel manipulator for orthopaedic application in the world, say the firm.
An integrated surgical system including both image-guided navigation and handheld drilling features, the robotic system streamlines procedural tasks and considerably reduces surgeon’s burdens during spinal fusion surgeries, and its outstanding performance on precision, stability, and reproducibility of robot motion can improve the surgical outcomes which used to strongly rely on the experience of the surgeon, according to Point Robotics.
Jackie Yang, the co-founder of Translink Capital (Palo Alto, USA), said: “Point Robotics is revolutionising spinal surgery by combining the clinical know-how garnered from years of surgeons’ experience and cutting-edge technologies.”
Point Robotics is preparing for CE marking in Europe and registration certificate in China to boost global deployments and to access international markets.
SC Juang, CEO of Point Robotics, added: “It’s our honour to make the worldwide debut of the cutting-edge robot system starting from the world’s largest surgical robot market—the USA. We aim to promote availability and affordability of robotic adoption for spinal surgery unaddressed by today’s technology to treat more patients who contracted spectrum of spinal diseases.”
