Guideways raises pre-seed funding to accelerate growth of agentic AI platform for medtech innovators

Dutch startup accelerates approval process for medical innovations with AI platform

Utrecht, The Netherlands, 10 November 2025 – Guideways, the AI company helping medtech innovators navigate complex regulatory and approval processes, has raised pre-seed funding from Healthy.Capital and Rising Star Venture Partners. The investment will be used to launch and further scale the Guideways AI platform. Guideways helps medical device companies obtain regulatory approval faster, enabling life-saving technologies to reach patients years earlier.

Every year, tens of thousands of promising medical technologies are delayed by the complexity of regulatory, quality, and reimbursement processes. These processes currently account for up to 75 percent of total medical technology development costs and can delay market entry by 31 to 66 months. Behind these delays are patients waiting for better care. Guideways applies agentic AI, AI agents capable of autonomous, expert-level reasoning, to break through this complexity. The platform automates specialized tasks such as regulatory guidance, document review, and research, allowing medtech teams to bring innovations to patients months or even years faster.

Alexander Habermeier, co-founder of Guideways:
“At Guideways, we believe healthcare should lead in technology, not lag behind. Our mission is simple: bring ten times more life-changing innovations to patients faster and even more safely. We are proud to have successfully completed this funding round. This investment will accelerate the development of our AI platform and help medtech innovators make their innovations available to patients worldwide much earlier.”

Simplifying and accelerating the approval process through specialized AI

With more than 30 years of combined experience in medical technology, the founders have seen firsthand how complex approval processes can block promising innovations. The Guideways platform automates the most time-consuming aspects of compliance through a suite of specialized AI agents, initially focused on the US FDA approval process:

• FDA Sherpa guides teams from a concept description to a detailed approval strategy, identifying the correct classification, pathway, guidance documents, and standards.
• FDA Reviewer performs in-depth reviews of regulatory submissions, assessing hundreds of documents for compliance and suggesting improvements.
• FDA Researcher enables natural language search across a knowledge base of more than 150,000 reference documents, intelligently combining information to answer complex questions.

The new funding will support the commercial launch, ongoing platform development, and expansion to European MDR approval processes and reimbursement pathways in 2026.

Saskia ten Siethoff, QA/RA Specialist at Flux Robotics:
“Using Guideways’ FDA Sherpa, we were able to quickly define our intended use and map out the correct FDA pathway for our latest vascular surgical robot. It not only saved time but also explained the reasoning behind the recommendations, which gave real confidence when navigating complex regulations.”

Martijn van de Giessen, CEO of Secuped:
“As a MedTech company, medical regulation has a major impact on our strategy and our path to market. Guideways makes it easy and accessible for us to quickly assess where we stand and how to move forward.”

Guideways partners with leading early-stage healthtech funds Healthy.Capital and Rising Star Venture Partners

Douwe Jippes, co-founder and managing partner at Healthy.Capital:
“The Guideways team has deep, firsthand insight into the problem they are solving. Their AI-driven solution helps companies bring innovations to market faster and more successfully by significantly reducing approval time and costs. This fundamentally changes how medical devices reach the market. It makes healthcare innovation more accessible and efficient, which aligns perfectly with Healthy.Capital’s mission to keep healthcare affordable and accessible.”

Benjamin Sieters, Investment Director at Rising Star Venture Partners:
“Guideways is an excellent example of a company with the potential to make a significant impact quickly. By addressing bottlenecks in the innovation pipeline, the company enables healthtech innovators to succeed and bring their solutions to the global market faster and more cost-effectively. We have seen firsthand how the Guideways platform reliably accelerates complex and expensive steps in the critical path to regulatory approval, compliance, and reimbursement. We are proud to support their mission to speed up access to important medical technologies.”