Health, Wellness & Biotech Robotics Startups

Point Robotics’ Surgical Robot Is Taiwan’s First FDA-Cleared

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The Food and Drug Administration just cleared the first surgical robot from a company in Taiwan.

Taiwan-based Point Robotics announced on Tuesday it received FDA clearance for its Kinguide Robotic-Assisted Surgical System, a handheld robot that can be used in orthopedic surgeries. 

The system creates 2D and 3D models of the anatomy and pinpoints where there needs to be a drill point. The robot acts like a “hand” for the surgeon to attach different surgical tools to and use for different procedures. It also balances shaky hands and guides the surgeon to make precise drills into the bone and add screws, making the process as minimally invasive as possible. 

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Point Robotics’ watershed FDA clearance is a large badge for Taiwan’s small health care and biotech industry. Funding in the space saw a 176.6% increase between 2019 and 2020, according to Crunchbase data, and went to only nine startups.

The next step for Point Robotics is to apply the surgical system to other types of spinal procedures like herniated disc decompression. It will also start pursuing approval in Europe and China.

The 6-year-old company raised $18 million in Series A funding in 2020 from Taiwania Capital, Translink Capital and through government-assisted funding. In January it raised an undisclosed sum of funding. 

The rise of orthopedic surgery

SpineAssist, the first spine robot, received FDA approval in 2004 with its ability to improve accuracy and decrease complications and recovery time. Precision is of utmost necessity in the spine to prevent long-term spinal problems or permanent damage to the spine, which could affect mobility or sensory experience. 

However, medical technology in orthopedic surgery is a massive upfront cost for hospitals and clinicians, and requires surgeons to train with the technology.

Mazor Robotics, an Israel-based company that owns a robotic guidance platform, was acquired by Medtronic in 2018. Mako Surgical, another orthopedic-focused robotics company, was acquired by Stryker in 2013 and has expanded its product line to assist in knee and hip surgeries.

Illustration: Dom Guzman

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