PlasmaSure™ Receives FDA Breakthrough Device Designation
Ilan Uchitel, CEO & Co-Founder of CAPS Medical, commented: “Receiving Breakthrough Device Designation is a strong validation of the clinical need for a safer, more accessible solution for NMIBC patients and of the differentiated potential of our PlasmaSure™ platform. This designation provides priority review and interactive communication with the FDA, more flexible clinical study design, and promising potential eligibility for CMS’s Transitional Coverage for Emerging Technologies pathway, supporting earlier and more predictable reimbursement.Our team is committed to turning this innovation into a new standard of care.”
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