Daily Newsletter

16 January 2024

Daily Newsletter

16 January 2024

Brain Navi’s neurosurgical robot used in 100th surgical procedure  

Brain Navi plans to submit a 510(k) application to the US Food and Drug Administration later this year for its CE marked NaoTrac robot.

Jenna Philpott January 16 2024

Taiwan-based surgical robot firm Brain Navi has revealed that the 100th procedure has been performed using its neurosurgical navigation robot, NaoTrac. 

The milestone was reached during a surgery conducted by Dr. Hao-Yu Chuang, the director of the neurosurgery department at Annan hospital in Tainan, Taiwan. 

NaoTrac utilises Surface Mapping Auto-Registration Technology (SMART), which combines robotics, artificial intelligence (AI) and machine vision to streamline surgical procedures with real-time images and less invasive outcomes. 

The NaoTrac system received CE-mark in April 2021 and Taiwan Food and Drug Administration (TFDA) approval in July 2022. 

Brain Navi previously reported that it was planning to file US FDA approval for the robot by the end of 2022, however the company now plans to file for a 510(k) clearance in 2024, as per the company website. 

In the announcement accompanying the procedure, Dr. Hao-Yu Chuang said: “One of the main benefits compared to other systems is that we can accurately register cranial anatomy in any patient position, including lateral and prone positions.” 

Brain Navi and Medtreq Medical teamed up in September 2022 to expand the distribution of its NaoTrac neurosurgical navigation robot in the Gulf Cooperation Council (GCC) region, Egypt, Jordan and other countries in the Middle East, as well as Indonesia, Singapore, the Philippines and Malaysia. 

According to a report on GlobalData’s Medical Intelligence Center, the robotics market was worth $63bn in 2022, and is forecast to grow at a compound annual growth rate (CAGR) of 17% to $218bn by 2030. GlobalData has identified surgical robots as a key innovation area in robotics, and Intuitive Surgical is one of the leading patent filers in the field. 

Earlier this month, EndoQuest Robotics and Omnivision partnered up to incorporate image sensor technology into surgical robotics after EndoQuest raised $42m in a C-1 preferred financing round led by CE Ventures and McNair Interests to advance the robotic system. 

Last week, Distalmotion announced a collaboration with Proximie to extend the capabilities of its Dexter robotic surgery system globally, Distalmotion customers with access to Proximie’s healthcare platform, designed to deliver telepresence, content management and data-driven insights. 

Healthcare industry continues to be highly vulnerable to cyberattacks

Cybersecurity is a growing market in the medical devices sector for several reasons. Medical devices often collect and contain vulnerable data, such as patient medical information. Legacy medical devices are a cause for concern because they likely were not designed with cyberattacks in mind. With the adoption of EHR systems, telemedicine measures, mobile health apps, and other connected devices, there is increased vulnerability to cyberattacks.

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