Announcing our successful pre-seed funding round
- Alexander Habermeier
- 4 days ago
- 2 min read
Updated: 9 hours ago
What if health technology could move at the speed of discovery?
At Guideways, we believe healthcare should be a leading adopter of technology. But every year tens of thousands of life changing innovations are slowed down by the complexity of regulation, quality and reimbursement, leaving patients waiting with undiagnosed issues or suboptimal therapies.
This has inspired our mission to get 10 times more innovations to patients, faster and even safer.
We are thrilled to announce today a key milestone on our journey. Guideways has successfully closed its pre-seed funding round led by Healthy.Capital together with Rising Star Venture Partners.
The capital will be deployed for the commercial launch and further development of the Guideways AI platform, focusing initially on a powerful suite of deeply specialized agentic AI tools for FDA approval.
FDA Sherpa: guides teams from a concept description to a detailed approval strategy, identifying the correct classification, pathway, requirements, and standards.
FDA Reviewer: performs in-depth checks of regulatory submissions, reviewing hundreds of documents for compliance and suggesting fixes.
FDA Researcher: searches through a knowledge base of more than 150,000 reference documents, combining information intelligently to answer complex queries.
We are fortunate to work closely with dozens of customers who share our vision…
Saskia ten Siethoff, QA/RA Specialist, Flux Robotics: “Using Guideways’ FDA Sherpa helped us quickly define our intended use and map out the right FDA pathway for our next-generation vascular surgery robot. It not only saved time but also explained the reasoning behind its recommendations; something that really built confidence to navigate complex regulations.”
Martijn van de Giessen, CEO, Secuped: “As a MedTech company, regulatory requirements have an enormous impact on our strategy and road to market. Guideways made it easy and accessible for us to quickly assess where we stand and how to proceed.”
… And to partner with leading early-stage funds that share our dedication to fostering transformative healthcare innovation.
Douwe Jippes, Co-founder and Managing partner at Healthy.Capital: "The team at Guideways has a deep, personal understanding of the problem they are solving. They help companies to bring innovations to market faster and more successfully by significantly reducing the approval time and costs, fundamentally changing how medical devices are brought to market. This makes healthcare innovation more accessible and efficient, which perfectly aligns with our mission at Healthy.Capital to make healthcare affordable and accessible."
Benjamin Sieters, Investment Director at Rising Star Venture Partners: "Guideways is a prime example of a company with the potential for fast and massive impact. By addressing barriers within the innovation pipeline, the company empowers health technology innovators to succeed and bring their solutions faster and more cost-effectively to a global market. We have seen first-hand how Guideways’ platform can reliably fast-track complicated and expensive steps in the critical route to regulatory approval, compliance and reimbursement. We are proud to back their mission to accelerate the availability of ground-breaking medical technologies."
Download the full press release below.
