Latest Insights
AI Strategy
May 20, 2026
16 mins read
Post-Market Surveillance for AI Medical Devices: Why CE Marking Is the Start, Not the Finish
A practical guide to EU MDR post-market surveillance for AI medical devices — distributional shift,…
Med Tech
May 20, 2026
15 mins read
SaMD Classification 101: How to Determine If Your Algorithm Is a Medical Device Before the Regulator Does
A practical guide for health AI founders on determining medical device classification across EU MDR…
Med Tech
May 20, 2026
16 mins read
FDA 510(k) vs De Novo vs PMA: Choosing the right regulatory pathway for your AI medical device
A practical guide to FDA pathway selection for AI medical devices — what determines which one appli…
16 mins read
Post-Market Surveillance for AI Medical Devices: Why CE Marking Is the Start, Not the Finish
A practical guide to EU MDR post-market surveillance for AI medical devices — distributional shift,…
Med Tech
May 20, 2026
15 mins read
SaMD Classification 101: How to Determine If Your Algorithm Is a Medical Device Before the Regulator Does
A practical guide for health AI founders on determining medical device classification across EU MDR…
Med Tech
May 20, 2026
16 mins read
FDA 510(k) vs De Novo vs PMA: Choosing the right regulatory pathway for your AI medical device
A practical guide to FDA pathway selection for AI medical devices — what determines which one appli…
Explore more topics
Med Tech
May 20, 2026
16 mins read
The 6-month roadmap: from healthcare AI concept to regulatory submission
A month-by-month sequence for taking a Class IIa healthcare AI product from concept to a complete E…
Med Tech
May 18, 2026
17 mins read
AI in Women's Health: The Regulatory, Data, and Algorithmic Challenges Nobody Talks About
A practical guide for founders and CTOs building diagnostic AI in fertility, menstrual health, horm…
Med Tech
May 13, 2026
11 mins read
Clinical validation of AI diagnostics: what the evidence actually needs to show
What clinical validation for AI medical devices actually requires under EU MDR and FDA: pre-specifi…
AI Strategy
May 12, 2026
16 mins read
The data problem in healthcare AI: how to train a clinical-grade model when you don't have enough patients
Practical data strategies for clinical AI when "collect more data" isn't available on startup times…
Med Tech
May 12, 2026
13 mins read
The Business Case for Cardiac AI Diagnostics: What It Actually Takes to Build and Ship
This is the strategic companion to our piece on Cardiac AI Diagnostics: The Engineering Behind ECG …
Med Tech
May 12, 2026
6 mins read
Cardiac AI Diagnostics: The Engineering Behind ECG Interpretation at Clinical Grade
This is the engineering companion to our piece on The Business Case for Cardiac AI Diagnostics. If …
Med Tech
May 08, 2026
7 mins read
From Prototype to Class IIa: How to Get Your AI Diagnostic CE Marked Without Losing 2 Years
Eight months.
That's how long it took KARDI AI to go from a working cardiac diagnostic prototype…
16 mins read
The 6-month roadmap: from healthcare AI concept to regulatory submission
A month-by-month sequence for taking a Class IIa healthcare AI product from concept to a complete E…
Med Tech
May 18, 2026
17 mins read
AI in Women's Health: The Regulatory, Data, and Algorithmic Challenges Nobody Talks About
A practical guide for founders and CTOs building diagnostic AI in fertility, menstrual health, horm…
Med Tech
May 13, 2026
11 mins read
Clinical validation of AI diagnostics: what the evidence actually needs to show
What clinical validation for AI medical devices actually requires under EU MDR and FDA: pre-specifi…
AI Strategy
May 12, 2026
16 mins read
The data problem in healthcare AI: how to train a clinical-grade model when you don't have enough patients
Practical data strategies for clinical AI when "collect more data" isn't available on startup times…
Med Tech
May 12, 2026
13 mins read
The Business Case for Cardiac AI Diagnostics: What It Actually Takes to Build and Ship
This is the strategic companion to our piece on Cardiac AI Diagnostics: The Engineering Behind ECG …
Med Tech
May 12, 2026
6 mins read
Cardiac AI Diagnostics: The Engineering Behind ECG Interpretation at Clinical Grade
This is the engineering companion to our piece on The Business Case for Cardiac AI Diagnostics. If …
Med Tech
May 08, 2026
7 mins read
From Prototype to Class IIa: How to Get Your AI Diagnostic CE Marked Without Losing 2 Years
Eight months.
That's how long it took KARDI AI to go from a working cardiac diagnostic prototype…