MedTech's European Money Map: what investors are betting on in 2026.
A founder's guide to European investors funding medtech in 2026, what they back, and what they want to see before they write the cheque.
What Dovetail’s Envoy Service Is, Why It's Different, and Why It's Working
At Dovetail, we believe in human judgement alongside brilliant AI. AI has brought unbridled efficiency to our work and intelligence to our fingertips that was previously inaccessible. You could have it build any document with the right context. It’s enough to do just about anything. But not everything. It
Introducing our new collaboration suite
We built our own AI-native collaboration suite, and the conversation now includes the Dovetail agent. It reads every comment and redline in your document and acts on it, right inside your ISO 13485 quality system. A huge time saver for teams, and it's available now for all users.
An agent that gets smarter where it counts: your device, your regulatory journey, and all of our experience.
Dovetail's agent learns from the decisions, facts, and expert feedback in your calls and written work, not just chats. It remembers what matters, keeps getting better for you, and keeps your data private.
Crossing the Atlantic? Four Things Every UK Medtech Founder Must Pack Before Facing the FDA.
America turns 250 this year. For UK medtech, the US market is still the market worth crossing an ocean for. Standing at the door to the US market is the FDA, and (surprise!) it works nothing like the MHRA or a Notified Body.
FormlyAI is now Dovetail.
Same team, same platform, new name. Our experts dovetail into your team, our platform dovetails into the tools you already use, and the device you've built reaches the people who need it most. That's why we're now Dovetail.
The FDA Q-Submission Process: A Medtech founder’s guide to the Pre-Sub
TL;DR A Q-Submission (most often a Pre-Sub) is a free, formal way to get FDA’s written feedback on your device and your submission plan before you file. You send a short package with specific questions, FDA responds in writing within about 75 days, and they usually
The AI Never Told Me: What the FDA's Warning Letter on AI Actually Means
A few weeks ago, the FDA sent a warning letter to Purolea Cosmetics Lab. It's been getting a lot of attention, mostly framed as a warning shot at AI in pharmaceutical manufacturing. "FDA says AI is a liability." That kind of thing. I want to offer
AI-first traceability that humans actually want to look at
Formly's new traceability matrix auto-links every requirement from User Needs through Validation, exposes that traceability graph to AI agents via MCP, and finally looks like something worth using.
Regulatory Intelligence and Workflows, Right Where You Work: Introducing Dovetail's MCP Server
Formly now has an MCP server. Connect your Formly workspace directly to Claude or GPT and run regulatory research, standards lookup, and expert review without switching tools.
Breaking into the US Medtech Market: What Founders Need to Know About the FDA.
Compared to other regulatory authorities across the world, the FDA’s approach to regulations and engaging with companies looking to clear their medical devices is unique. The predicate system, enforcement discretion products, and the De Novo pathway, to name a few, are regulatory concepts that are unlike most other countries.
FormlyAI raises $2M led by Heal Capital to revolutionize medical device compliance using AI
New capital to accelerate US market expansion, scale EU operations, and further develop its AI-powered platform that has already saved clients an average of $70K and reduced time-to-market tenfold. CHARLESTON, September 11, 2025 – FormlyAI, the only AI-native solution for medical device certification, today announced the closure
