Onward’s Arc-Ex earned FDA 510(k) clearance for use at home, according to a Nov. 17 news release.
The device is cleared for “use in conjunction with functional task practice in the clinic and take-home exercises in the home to improve hand strength and sensation in adults with chronic, non-progressive neurological deficits resulting from an incomplete SCI (C2-C8 inclusive),” the release said. Arc-EX is a noninvasive device that delivers programmed, transcutaneous electrical spinal cord stimulation.
“Today’s authorization expanding the ARC-EX System indication for home use greatly enlarges the US market opportunity and is a defining milestone for the spinal cord injury community,” Onward CEO Dave Marver said in the release. “People living with SCI will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes.”
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
