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.
The “NaviFUS Focused Ultrasound System” developed by NaviFUS Corporation recently won Gold at the 2022 Edison Awards – Science & Medical Outpatient Treatment category on Apr. 22, 2022. Also competing in this category were other innovative products by renowned companies Abbott Laboratories and Spark Biomedical.
NaviFUS Corporation’s “Neuronavigation-guided Focused Ultrasound System” has recently been shortlisted for the 2022 Edison Award – Science & Medical Outpatient Treatment category – together with global pharmaceutical giant Abbott and Spark Medical Inc. (market value: US$4.4 billion). Final results for the gold, silver, and bronze medals will be announced in April in Florida, USA. The news is an affirmation that NaviFUS can compete side by side with other first-rate companies around the world, and Taiwan’s innovative talent is once again visible on the world stage.
We’re not keeping it a secret anymore. We are proud to announce NaviFUS® Model 101 has been chosen for the 2022 Edison Awards Finalists in Outpatient Treatment
The Finalists of the 2022 Edison Best New Product Awards® were chosen as the “best of the best” by 3000 of the world’s top senior business executives, academics, and innovation professionals.
We are excited to announce that NaviFUS® Model 101 Neuronavigation-guided focused ultrasound system is nominated for the 2022 Edison Awards! Congratulations to our team members for the incredible work they do! The Edison Awards™, named after Thomas Alva Edison, is a leader in globally recognizing, honouring and fostering innovation and innovators to create a positive impact in the world.
Pilot Study of Focused Ultrasound for Drug-Resistant Epilepsy
Researchers in Taiwan recently published the data from a small pilot clinical trial testing the safety and efficacy of using focused ultrasound to provide neuromodulation for patients with drug-resistant epilepsy.
Participants received low-intensity focused ultrasound in the seizure origination zone from the NaviFUS neuronavigation-guided system.
Results from a study published in Epilepsia suggest that focused ultrasound, which can be used to non-invasively target circuits in the brain, may benefit some patients with epilepsy who experience seizures that do not respond to standard anti-seizure medications.
Results from a study published in Epilepsia suggest that focused ultrasound, which can be used to non-invasively target circuits in the brain, may benefit some patients with epilepsy who experience seizures that do not respond to standard anti-seizure medications.
In the study of six patients with drug-resistant seizures, two patients had fewer seizures within three days of receiving focused ultrasound; however, one patient showed signs of more frequent subclinical seizures (which are not felt by the individual).
Imaging tests after the treatment revealed no negative effects on the brain. One patient reported feeling heat on the scalp during the treatment, and one patient experienced temporary memory impairment that resolved within three weeks.
The annual meeting of the CNS was held October 16-20 in Austin, Texas.
Suzanne LeBlang, MD, presented recent advances in focused ultrasound for treating brain tumors. She covered research using focused ultrasound for blood-brain barrier opening and drug delivery, radiation sensitization, and sonodynamic therapy to treat glioblastomas. She also addressed focused ultrasound–enhanced liquid biopsy for the diagnosis and monitoring brain tumors. The presentation also featured data from recent clinical trials using the Insightec, NaviFUS, and CarThera devices, which each use a different method for guidance.
NaviFUS Founder & Chief Technical Consultant Hao-Li Liu, Ph.D. also participated in the virtual workshop this year. He presented the seminar Neuronavigation-Guided Focused Ultrasound: A Platform for Accelerating the Treatment of CNS Disease on October 8th, 2021. He shared the results of innovative research using the NaviFUS® with microbubbles to 1) open the Blood-brain barrier (BBB) and enhance CNS drug delivery and 2) neuromodulation for better treatment outcomes.
NaviFUS Corp. Founder & Chief Technology Consultant Dr. Hao-Li Liu will present on the topic of Neuronavigation Focused Ultrasound Induced CNS Intervention. He will share results of innovative research using the NaviFUS® (Neuronavigator-guided transcranial focused ultrasound system) in enhancing CNS drug delivery, neuromodulation, and opening the Blood-brain barrier (BBB) with FUS energy for better treatment outcomes.