Dutch AI firm Guideways, serving to medtech companies navigate regulatory and compliance, has raised pre-seed financing.
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Utrecht-based Guideways, an AI firm serving to medtech companies navigate regulatory and compliance complexity, has raised pre-seed financing from Wholesome.Capital and Rising Star Enterprise Companions.
Wholesome.Capital is an early-stage funding fund centered on healthcare startups with a imaginative and prescient of reworking healthcare by means of know-how.
Douwe Jippes, Co-founder and Managing Accomplice at Wholesome.Capital, says, “The staff at Guideways has a deep, private understanding of the issue they’re fixing. They assist firms to deliver improvements to market quicker and extra efficiently by considerably decreasing the approval time and prices, essentially altering how medical units are delivered to market. This makes healthcare innovation extra accessible and environment friendly, which completely aligns with our mission at Wholesome.Capital to make healthcare reasonably priced and accessible.”
Fund utilisation
The corporate will utilise the funds to launch and scale its agentic AI platform, designed to help medical system firms in attaining regulatory approval and delivering lifesaving applied sciences to sufferers years quicker.
Moreover, the funding can even assist the industrial launch actions, ongoing platform improvement, and enlargement towards European MDR and reimbursement frameworks in 2026.
Guideways: Targeted on FDA approval of medical units
Based by Sander Denissen and Alexander Habermeier, Guideways.ai is an AI firm that helps medtech companies navigate regulatory complexity.
Yearly, tens of 1000’s of promising medical applied sciences are slowed down by the complexity of regulation, high quality and reimbursement.
These processes at the moment eat as much as 75 per cent of medtech improvement prices and might delay market entry by 31 to 66 months.
The Dutch firm has developed AI brokers that lower by means of regulatory approval, compliance, and reimbursement complexity for medtech innovators.
The corporate’s platform automates probably the most time-consuming components of compliance by means of a collection of specialized AI brokers, centered initially on the US FDA approval course of:
FDA Sherpa: Guides groups from an idea description to an in depth approval technique, figuring out the right classification, pathway, necessities, and requirements.FDA Reviewer: Performs in-depth checks of regulatory submissions, reviewing lots of of paperwork for compliance and suggesting fixes.FDA Researcher: Permits natural-language exploration of a information base of greater than 150,000 reference paperwork, combining info intelligently to reply complicated queries.
Benjamin Sieters, Funding Director at Rising Star Enterprise Companions, says, “Guideways is a major instance of an organization with the potential for quick and large affect. By addressing boundaries throughout the innovation pipeline, the corporate empowers well being know-how innovators to succeed and produce their options quicker and extra cost-effectively to a world market.”
We’ve got seen first-hand how Guideways’ platform can reliably fast-track difficult and costly steps within the vital path to regulatory approval, compliance and reimbursement. We’re proud to again their mission to speed up the supply of groundbreaking medical applied sciences,” concludes Sieters.
