The US Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded use of Onward Medical’s ARC-EX System, now permitting individuals with spinal cord injuries (SCI) to use the device at home, as well as in clinical settings.

This cleared indication covers adults with long-standing, non-progressive neurological impairments originating from an incomplete SCI, aiming to enhance hand strength and sensation through both supervised rehabilitation and home exercise routines.