Onward Medical Granted FDA Approval for Home Use of Its ARC-EX System
Onward Medical has received FDA 510(k) clearance to expand the use of the ARC-EX system for home use in the United States, according to the press release.
Onward Medical's ARC-EX system, designed to enhance hand strength and sensation for individuals with spinal cord injuries, has been acquired by over 60 American clinics this year. While no specific financial figures were disclosed in this release, the deployment of the system across these clinics indicates a growing market adoption.
Expanded Use Authorization
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According to Onward Medical, the FDA's authorization now allows the ARC-EX system to be used in conjunction with functional practices in clinics and with home exercises. The non-invasive transcutaneous spinal cord electrical stimulation system is intended for use by rehabilitation professionals in medical centers as well as at home by patients, or with the assistance of others if necessary.
Significant Access Expansion
The FDA's decision represents a significant expansion of access to the ARC-EX system, which is already available in over 60 American clinics. The company reports that a study, Up-LIFT, showed that 90% of participants noticed an improvement in strength or function, with benefits observed up to 34 years post-injury. The results of the latest study, LIFT Home, suggest that continued use of the ARC-EX system at home is effective in maintaining and extending gains achieved in clinical settings.
Launch of ARC-EX continues to be a resounding success...
Risks mentioned
Retard dans les approbations réglementaires pouvant affecter les délais.
Concurrence accrue dans le secteur de la neurotechnologie.
Opportunities identified
Lancement du système ARC-EX avec succès aux États-Unis.
Récupération de la demande soutenue pour la technologie de stimulation.
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