The State Food & Drug Administration (SFDA) from the People’s Republic of China has given clearance to Devon Medical Products to market the ViewSite brain access system.
The ViewSite is a brain access and retraction device that allows higher precision for surgeons in reaching target areas in the brain, such as tumors and haemorrhages, in a minimally invasive manner. This neurosurgery device helps surgeons see surrounding tissue better during surgery and allows them to reposition the retractor fewer times during the procedure. The result is higher accuracy, less tissue trauma, and potentially faster recovery for patients.
The ViewSite is made in the United States by Vycor Medical, a medical device company specialising in products for neurosurgery. Devon Medical Products is Vycor’s distributor in China.
“This regulatory approval has significant implications for surgeons and patients who will be able to benefit from the ViewSite device in China as they have in the United States,” said John A Bennett, president and CEO of Devon Medical Products. “Our goal is to help sell US made medical devices to the rest of the world to both support the US economy but also improve quality of care where needed in other countries. We are excited to continue our strong relationship with Vycor Medical, and are proud to be working with a healthcare industry giant like PKU BeiYi Pharmaceutical Co Ltd to bring this innovative device to Asia.”
“The ViewSite has received outstanding reviews from surgeons in the United States where it continues to gain traction with hospitals and neurosurgeons,” said Kenneth T Coviello, CEO of Vycor Medical. “We are excited to begin working with healthcare professionals in China and look forward to the expansion of ViewSite in Asia where we believe there is tremendous potential.”