FDA Clearance for NervAlign® Nerve Cuff
11th of February 2022: Melbourne Australia: ReNerve Ltd today announced it has received market clearance from the FDA for its NervAlign® Nerve Cuff device. This means the company can now market and sell the product in the United States. The NervAlign Nerve Cuff is a Class II medical device.
“Well done to the team. This is a major step forward for ReNerve as it progresses from an R&D orientation towards building a portfolio of commercialised products focussed on the nerve repair market” said Chair Mr Stephen Cooper.
FDA Approval