ONWARD Medical Secures FDA Clearance For ARC-EX System Home Use

(RTTNews) - ONWARD Medical N.V. (ONWRF, ONWDB.XD, ONWD.BR) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indication of its ARC-EX System for home use.

The FDA has cleared the ARC-EX System to be used alongside functional task practice in clinical settings and take-home exercises to improve hand strength and sensation in adults living with chronic, non-progressive neurological deficits caused by an incomplete spinal cord injury (SCI) at levels C2-C8.

This milestone broadens access to ONWARD's innovative therapy, enabling patients to continue rehabilitation beyond the clinic and into their homes.

Commercially available for less than one year, the ARC-EX System is now accessible in more than 60 clinics across the US.

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