FDA clears SaluMedica's biomaterial nerve repair cuff:
This article was originally published in Clinica
Executive Summary
SaluMedica has received US FDA 510(k) clearance to market its biomaterial for use in peripheral nerve repair. The Salubria nerve cuff is a flexible tube that provides a protective environment to help peripheral nerves grow back together after they have been severed or damaged. Available with inner diameters of 2mm, 5mm and 10mm, it is made from the company's hydrogel, named Salubria. Atlanta, Georgia-based SaluMedica, which changed its name from Restore Therapeutics, says the product avoids the need to remove a vein or nerve from another part of the patient's body.