NaivFUS NAVIRFA® Scope gains regulatory approval from Taiwan FDA and US FDA, aims to begin sales in second half of 2022
On May 9th, 2022, NaviFUS Corporation (6872), an innovator of focused ultrasound technology announced that its NAVIRFA® Scope product has consecutively received approvals for the Sales License for Class II Medical Device from TFDA (Taiwan Food and Drug Administration) and the 510(K) Premarket Notification from US FDA in early May.
NaviFUS announced that it expects to begin sales of NAVIRFA® Scope on the Taiwan market with Unipharma as its distributor in the second half of this year. At the same time, it will also start new product development for the NAVIRFA® Scope on dendritic cell (DC) immunotherapy to help treat liver cancer patients.
The NAVIRFA® Scope combines ultrasound with optoelectronics and single-lens image analysis to create the world’s first radiofrequency ablation (RFA) needle tracking system. The core patent technologies were developed by NaviFUS founder and Chief Technical Consultant Dr. Hao-Li Liu, who is also an Electrical Engineering professor at National Taiwan University.
NavIFUS stated that conventional abdominal radiofrequency ablation requires opening one or more small holes in the abdomen and performing tumor ablation in the complex abdominal cavity. Doctors often must use non-invasive imaging techniques such as ultrasound or computed tomography (CT) in order to know the correct location of the lesion.
While ultrasound scans are one of the most commonly used imaging procedures, they can only provide a two-dimensional slice of the target area. Thus, it is not easy to guide a needle deep into the abdominal cavity accurately without trial and error to reach the correct tumor location during surgery.
The NAVIRFA® Scope is like a GPS navigational system for needle-based procedures, allowing doctors to know the location of the needle tip at any given moment, which allows them to solve problems swiftly and accurately.
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