Guideways raises capital to accelerate medtech approvals with AI
Guideways, a company that helps medtech innovators navigate complex regulations and approval processes, has raised new funding.
Published on November 10, 2025
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Guideways, an AI company that helps medtech innovators navigate complex regulations and approval processes, has raised new funding. With this investment, the company will launch and scale its AI platform, enabling medical devices to obtain regulatory approval faster and bringing life-saving technologies to patients years earlier. Guideways has secured pre-seed funding from Healthy.Capital and Rising Star Venture Partners.
Every year, tens of thousands of medical technologies are delayed by the complexity of regulatory, quality, and reimbursement processes. These processes currently account for up to 75% of medical technology development costs and can delay market introduction by 31 to 66 months. Behind those delays are patients waiting for better care.
Guideways applies agentic AI (AI agents that reason independently at an expert level) to break through this complexity. The platform automates specialist tasks such as regulatory advice, document review, and research work, enabling medtech teams to bring their innovations to patients months or even years faster.
Alexander Habermeier, co-founder of Guideways: “We are proud to have successfully completed our funding round. This investment will accelerate the development of our groundbreaking AI platform and help medtech innovators make their innovations available to patients worldwide much sooner.”
Series of specialized AI agents
The Guideways platform automates the most time-consuming aspects of compliance through a series of specialized AI agents, which initially focus on the US FDA approval process:
FDA Sherpa: guides teams from a concept description to a detailed approval strategy, identifying the correct classification, route, guidelines, and standards.
FDA Reviewer: performs thorough checks of approval applications, assesses hundreds of documents for compliance, and makes suggestions for improvements.
FDA Researcher: enables natural language searches of a knowledge base of over 150,000 reference documents, intelligently combining information to answer complex questions.
The new funding will support the commercial launch, ongoing platform development, and further expansion into European MDR approval processes and reimbursement processes in 2026.
New vascular surgery robot
Saskia ten Siethoff, QA/RA Specialist, Flux Robotics: “Using Guideways' FDA Sherpa, we were able to quickly define our intended use and map out the right FDA path for our latest vascular surgery robot. Not only did it save time, but it also explained the reasons behind the recommendations, which really gave us confidence to navigate complex regulations.”