gyzmoo schreef op 28 mei 2025 19:52:
Dear xxx,
Thank you for reaching out and for your interest in the ARCEX System!
At this time, the ARCEX System is authorized for professional use within U.S. clinics only and is not yet available for individual home use. ONWARD is actively working on securing FDA clearance for home use, with plans to apply for a label extension in the coming months. We anticipate approval by end of 2025.
We're committed to making our therapies available as quickly as possible and will keep you updated on future availability. Please let us know if you have any further questions.
Best regards,
Jennifer Schwab
ONWARD Customer Experience Team