Founded in 2024 in Utrecht, Guideways builds an AI platform composed of specialized agents—FDA Sherpa, FDA Reviewer, and FDA Researcher—that help medical-device companies map regulatory pathways, review submission packages, and query a 150,000-document knowledge base. The system targets the U.S. FDA process first, where regulatory, quality, and reimbursement hurdles can consume up to 75% of development costs and delay launches by up to 66 months. By automating the most time-consuming compliance tasks, the company aims to get ten times more life-changing technologies to patients faster and at lower cost. Early users such as Flux Robotics and Secuped report that the platform clarifies intended use, selects the correct pathway, and reduces strategic uncertainty. Guideways plans to extend coverage to European MDR and reimbursement frameworks in 2026. The recent pre-seed capital provides the first external funding for commercial launch activities and continued product development.

Total raised

$1M

Funding rounds

1

Latest round

Seed

Latest activity

Nov 2025