23 May 2012 | News | By BioSpectrum Bureau
ActiViews gets SFDA nod for needle guidance system
Chinese SFDA approves ActiViews product
Singapore: ActiViews, a company pioneering the development of simple, accurate, and cost-effective surgical navigation solutions, received clearance to market CT-Guide navigation for minimal invasive interventions, from the China's State Food and Drug Administration (SFDA).
CT-Guide navigation is designed to assist physicians during CT-guided interventional diagnostic and therapeutic procedures, including percutaneous biopsies, ablations, and marker placements in the lung and liver. CT-Guide navigation shows physicians the real-time location of their interventional instruments and the trajectory to target on the CT images like a GPS guides a car using stored roadmaps.
Mr Yuval Zuk, CEO, ActiViews, said that, "Following our two year process, the ActiViews team and I are extremely pleased that the Chinese SFDA recognizes the value of CT-Guide navigation. We are also delighted to be able to deliver our unique and simple technology into China, as this will enable us to expand our geographical presence into one of the world's fastest growing medical device areas."
China has more than 5,000 interventionists at clinical centers around the country that could benefit by having access to a soft tissue navigation system utilizing the ActiViews unique core technology. The Chinese government is committed to develop the country's healthcare system and is working to create a solid platform for universal healthcare access for all by 2020. This reform led to a significant growth for the medical device market, which is growing at a pace of 20-24 percent per year, with the 2014 estimate to reach $40-50 billion.
Mr Christopher von Jako, president, ActiViews, said that, "This registration clearance is a significant accomplishment for ActiViews and supports our global clinical strategy to penetrate markets that are accepting of novel minimal invasive technologies. It connects us more closely to Chinese physicians wanting to utilize clinically relevant devices that strive to improve their patients' health and wellness. We are excited to begin working with Chinese healthcare professionals later this year."