Point Robotics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August this year, and has received approval from Taiwan's Food and Drug Administration (TFDA) for the registration of medical devices, following the 510(k) clearance of the POINT™ Kinguide Robotic-Assisted Surgical System (formerly known as the "minimally invasive spine surgery robot").
After obtaining approval in Taiwan and the United States, the company will proceed with commercialisation in other markets, including Europe, Southeast Asia and China, in order to accelerate its global commercialisation and international footprint.
The patented parallel robotic design is unique in the world, and its high-precision navigation system provides real-time tracking to help surgeons complete spinal fusion surgeries with precision. In the future, the product will cover more spinal surgery indications, such as decompression surgery.
The two main products of Biosurgery - the "Kinguide Robotic-Assisted Surgical System" and the "Kinguide Agile Hybrid Navigation System" - have been approved for marketing in Taiwan this year and have been introduced to Taiwan medical institutions for clinical trials.
Founded in 2016, the company inherited its basic technology from Brian Davies, an honorary professor at Imperial College London, with over 30 years of academic research in the field of surgical robotics. It aims to become the "Da Vinci" of orthopaedic surgery by digitising the excellent and rich orthopaedic surgery experience of Taiwan surgeons and creating a comprehensive orthopaedic surgery platform of "master surgery" to provide safe and effective minimally invasive surgical solutions.
In May 2020, Point Robotics completed its Series A fundraising and received funding from government funds, Taiwan Capital and Translink Capital in Silicon Valley. The company will continue to focus on the development and certification of next-generation products to ensure its leadership position in the high-end surgical robotic market.
For more information please visit www.pointroboticsinc.com
