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FDA clears Onward’s ARC-EX System for home use in spinal cord injury care

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 ...
Business Insider

ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury

Empower BP is a landmark global pivotal study evaluating the safety and effectivenessof the implantable ARC-IM ® Systemto address blood pressure instability after spinal cord injury (SCI) Blood ...
Seeking Alpha

ONWARD Medical Receives CE Mark for ARC-EX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe

The CE Mark certification allows marketing for both clinic and home use First commercial sales of the ARC-EX ® System in Europe are expected in Q4 2025 The CE Mark enables commercialization in the ...
Seeking Alpha

Concurrent Publications in Nature and Nature Medicine Highlight Advances in Blood Pressure Regulation after Spinal Cord Injury Using ONWARD ARC-IM Therapy

Detailed results from clinical feasibility studies show immediate improvement in blood pressure stability and durable reduction of hypotensive symptoms, resulting in improved quality of life Most ...
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ONWARD Medical Announces First Participant Enrolled in Global Pivotal Study Evaluating ARC-IM System to Address Blood Pressure Instability After Spinal Cord Injury

EINDHOVEN, the Netherlands, Feb. 04, 2026 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the neurotechnology company pioneering spinal cord stimulation therapies to ...