Guideways launches AI platform to get life-changing medical devices to patients years faster

Every year, tens of thousands of promising medical technologies that could save or improve patients’ lives are delayed by regulatory complexity. Guideways, the AI company built to solve this problem, today launches its agentic AI platform to help medical device teams reach patients faster. The platform deploys specialized AI agents that guide teams through FDA approval, from identifying the optimal regulatory strategy for a new device concept, to researching the applicable standards and requirements, to reviewing submissions for gaps.

Regulatory and compliance processes consume up to 75 percent of medtech development costs and can push time to market back by 31 to 66 months. Two thirds of FDA submissions accepted for review receive a letter from the agency requiring additional work. Guideways’ platform is now available to medtech teams seeking FDA approval, cutting through some of the most time-consuming and costly steps in bringing a device to market.

Guideways applies agentic AI to automate the most demanding parts of regulatory work. Where generic AI tools produce unreliable outputs on complex regulatory questions, Guideways uses purpose-built agents and a curated knowledge base of more than 150,000 FDA reference documents, with expert workflows that mirror how experienced regulatory teams approach approval. The result is structured, explainable and traceable output that regulatory teams can review, document and defend.

Alexander Habermeier, Co-founder and CEO of Guideways: “With Guideways, we give medtech teams earlier regulatory clarity so they can move faster and make better decisions from day one. Behind every delayed or cancelled approval are patients waiting for better care. Our platform gives medtech teams the regulatory expertise they need, available at any time and cost effectively. While we launch with a focus on the U.S. FDA process, we are already expanding toward European MDR within our Explorers early access program.”

Three agents, one platform

The Guideways platform launches with three specialised AI agents, each targeting a different phase of the FDA approval process:

• FDA Sherpa guides teams from a plain-language device concept to an underpinned regulatory approval strategy, showing how to get approved and what is required at each step.
• FDA Reviewer helps teams find gaps and inconsistencies in regulatory submissions before regulators do, reducing the risk of delays, questions and rework.
• FDA Researcher delivers deep, evidence-backed regulatory answers without the need to manually search and cross-reference dozens of documents.

Bram van Rens, CTO and Co-Founder, PrecorDx

“The regulatory landscape can be complicated for a startup developing a new-to-world modality like ours. Guideways allowed us to quickly map out possible paths to FDA clearance, giving us the confidence to move forward.”

Liz Munro, Liz Munro Consulting

“I routinely review regulatory precedent for early-stage companies. Guideways has automated this process, quickly analysing suitable product codes and predicates which I can review in detail when formulating the overall regulatory strategy. Guideways saves me time and I feel confident in the results (vs general AI which routinely hallucinates codes and devices).”

First medtech platform to apply agentic AI to regulatory approval and compliance General-purpose large language models have shown consistent failure modes on regulatory tasks: invented product codes, contradictory pathway recommendations and logic that skips prerequisite checks. Guideways addresses these directly by grounding every output in validated regulatory data, applying specialist workflows that follow the actual decision logic of regulatory experts, and using multi-step reasoning to check prerequisites before proceeding.

Sander Denissen, Co-founder and CTO at Guideways: “Regulatory knowledge is scarce and often inaccessible. Progress stops when expertise is unavailable. We built Guideways to change that. You interact with the platform in natural language. It draws on over 150.0000 curated regulatory source documents to guide you from device description through classification, applicable controls, and in-depth technical file review. Every conclusion is traceable to exact sources: specific guidance pages, recognized standards, regulatory citations. This isn’t search. It’s an always-available regulatory support team.”

You can download the full press release below.