Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee. Starting at $2,000 USD per year for the first device (excludes government fees). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.
The CMS and FDA RAPID Coverage Pathway 2026 accelerates Medicare access to breakthrough medical devices by aligning regulatory approval and coverage decisions. It enables early CMS–FDA collaboration, shared clinical evidence, and same-day proposed coverage decisions upon FDA authorization. Eligible devices include certain Class II and Class III breakthrough devices studied in Medicare populations, reducing coverage timelines from over a year to approximately two months.
From launching AI-driven regulatory solutions to expanding our global footprint, it was a year of meaningful milestones and shared moments.
Explore articles and insights our team has published in leading media and industry platforms.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
