Regulatory strategy for AI/ML-enabled devices, training and validation best-practices, pre-sub questions, and more
FeaturedArticleAI/ML
For AI SaMD founders deciding how much to raise and how long the first FDA 510(k) will take. A 37-company benchmark: $16.0M mar...
Yujan Shrestha
FeaturedArticleAI/ML
Deep dive into four FDA De Novo and 510(k) submissions for AI-powered whole slide image analysis in pathology: Paige Prostate (...
Maddie Tran & Yujan Shrestha
FeaturedArticleAI/ML
For founders, CEOs, and CFOs at AI/ML medical device companies trying to decide how much to spend on a 510(k). A meta-analysis ...
Yujan Shrestha
FeaturedArticleAI/ML
FDA cleared 24 AI/ML SaMD applications in March 2026 — one every 31 hours. A breakdown of the patterns that matter for sponsors...
Yujan Shrestha
FeaturedArticleAI/ML
FDA's glossary defines foundation models as AI models trained on large, typically unlabeled datasets that are adaptable across ...
Yujan Shrestha
FeaturedArticleAI/ML
Fifty-one FDA-authorized pathology AI devices through April 2026, only seven of which are whole-slide imaging algorithms. This ...
Yujan Shrestha
FeaturedArticleAI/ML
A deep dive into the 97 cleared cardiovascular AI/ML SaMD devices, the four archetypes that organize them, and what they reveal...
Yujan Shrestha
FeaturedArticleAI/ML
Why digital health companies keep dying before and after FDA authorization, the evidence-reimbursement trap strangling the sect...
Yujan Shrestha
FeaturedArticleAI/ML
AI-assisted medical device development is FDA-compliant when done right. The obstacle isn’t regulation. It’s the messy codebase...
Yujan Shrestha
FeaturedArticleAI/ML
Comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights.
Yujan Shrestha
FeaturedArticleAI/ML
44 clearances. 18 in 2025 alone. The dental AI market has reached its tipping point. This report dissects the Pearl/Overjet duo...
Yujan Shrestha
FeaturedArticleAI/ML
A data-driven look at 2025’s AI/ML 510(k) clearances: volume, review times, SaMD share, leading specialties, top manufacturers,...
Yujan Shrestha
FeaturedArticleAI/ML
Deep dive into FDA 510(k) K252366, a2z‑Unified‑Triage, a radiology triage and notification device. Explains why the triage indi...
Yujan Shrestha
FeaturedArticleAI/ML
Breakthrough Device Designation (BDD) is a free, fast FDA program that signals serious unmet need and potential meaningful impr...
Yujan Shrestha & George Hattub
FeaturedArticleAI/ML
Setting acceptance criteria incorrectly (too high or too low) can delay your FDA submission by weeks or trigger rejection. This...
Yujan Shrestha
FeaturedArticleAI/ML
This article shows how to achieve an AI/ML SaMD 510(k) submission in ~3 months by running a compact, well-powered MRMC study wh...
Yujan Shrestha
FeaturedArticleAI/ML
Here we analyze over 200 FDA 510(k) and De Novo summaries to tease out best practices for AI/ML study designs and adjudication ...
Yujan Shrestha
FeaturedArticleAI/ML
A practical guide for engineers new to medical imaging AI, highlighting common pitfalls—like coordinate-system errors and orien...
Yujan Shrestha
FeaturedArticleAI/ML
Ideas on how to get foundation models and generative AI FDA cleared.
Yujan Shrestha
FeaturedArticleAI/ML
Recent advancements in radiology have led to the development of foundation models integrating vision and language capabilities,...
Yujan Shrestha
ArticleAI/ML
27 AI/ML medical devices authorized in April 2026. Radiology's share of clearances dropped from 79% to 56%, QIH remains the reg...
Yujan Shrestha
ArticleAI/ML
TytoCare's De Novo cracked open ENT, a specialty with just five prior AI/ML clearances, and dropped a 510(k) on-ramp for everyo...
Yujan Shrestha
ArticleAI/ML
From solo clinicians prototyping algorithms to enterprise teams shipping production software, tools like Cursor, Claude Code, C...
Yujan Shrestha
ArticleAI/ML
The U.S. Senate HELP Committee confirmed what we've been publishing for three years. An analysis of the regulatory signal, what...
Yujan Shrestha
ArticleAI/ML
A step-by-step guide to using Monte Carlo simulation for estimating the sample size needed to pass Bland-Altman Limits of Agree...
Yujan Shrestha & Nishant Dahal
GuidanceAI/ML
This FDA guidance clarifies which clinical decision support (CDS) software functions are excluded from the definition of a medi...
Valeriia Zakrasniana
ArticleAI/ML
Yujans commentary on the new Non-invasive blood pressure measuring device FDA guidance document in response to WHOOP and others.
Yujan Shrestha
ArticleAI/ML
A deep dive into K232613 (CT Cardiomegaly)
Yujan Shrestha
ArticleAI/ML
6 FDA clearances in 10 days. The AI pace is accelerating. Coverage includes neuro, dental, diabetes, and ADHD. Key wins: Nobel ...
Yujan Shrestha
ArticleAI/ML
Fifteen AI/ML software 510(k) clearances landed in nine days in mid-December 2025. Here’s what got cleared, where it fits clini...
Yujan Shrestha
ArticleAI/ML
Analysis of K252086 (DTX Studio Assist), a strategic 510(k) clearance for a 'headless' SDK. This submission minimizes regulator...
Yujan Shrestha
ArticleAI/ML
A client called out the “consultant thing”: hiding behind “ideally” instead of recommending a real plan. This piece explains wh...
Yujan Shrestha
ArticleAI/ML
This article explains Bland–Altman analysis for evaluating agreement between two continuous measurement methods, especially in ...
Yujan Shrestha
ArticleAI/ML
Most first-time teams burn over a year overbuilding documentation FDA never asks for. Here is a section-by-section breakdown of...
Yujan Shrestha
ArticleAI/ML
Command Line as a Medical Device (CLaMD) represents a streamlined approach to FDA clearance for medical software. By utilizing ...
Yujan Shrestha
VideoAI/ML
Kris Huang led a discussion on key image processing techniques in medical imaging, focusing on CT and MRI scans. Topics include...
Kris Huang
VideoAI/ML
The document details the process and significance of Clinical Performance Assessments (CPAs) for medical devices, focusing on t...
Ethan Ulrich
VideoAI/ML
Discussion covered key takeaways from the RSNA conference, balancing safety with speed, and setting risk thresholds. Topics inc...
Yujan Shrestha & 2 others
VideoAI/ML
This is a recording of the talk Yujan gave at the RSNA AI Theater
Yujan Shrestha
VideoAI/ML
The discussion explores generative AI (GenAI) in medical devices, focusing on FDA's considerations for regulation, risks, and t...
Yujan Shrestha & J. David Giese
VideoAI/ML
Dr. Elena Sizikova's presentation highlights the role of synthetic data in addressing data scarcity and privacy challenges in m...
Yujan Shrestha
VideoAI/ML
Yujan and David discussed the topic of FDA's performance in regulating AI medical devices, focusing on the ideal regulatory sit...
Yujan Shrestha & J. David Giese
VideoAI/ML
A 10x talk exploring the basics of prompt engineering, followed by an open-ended discussion.
VideoAI/ML
The talk covers device changes and their regulatory implications using FDA guidance. It focuses on two key documents for decidi...
Mary Vater
ArticleAI/ML
The article outlines a method for documenting AI/ML algorithms for FDA pre-submissions. It emphasizes clear algorithm descripti...
Yujan Shrestha
ArticleAI/ML
With predetermined change control plans (PCCPs), FDA has given manufacturers a great new regulatory tool. In this article, we d...
J. David Giese
ArticleAI/ML
Tips and FAQs on how to get a foundation model FDA 510(k) or De Novo cleared.
Yujan Shrestha
ArticleAI/ML
What is the difference between user needs and requirements?
Yujan Shrestha
ArticleAI/ML
Learn how to avoid invalidating your test dataset while still allowing yourself some flexibility to re-use the test data.
J. David Giese
VideoAI/ML
This video discusses the potential avenues for getting generative AI applications cleared through FDA.
Yujan Shrestha
ArticleAI/ML
This article outlines the process of developing an AI/ML algorithm from scratch and getting it FDA cleared. It covers the four ...
Yujan Shrestha
ArticleAI/ML
This article provides a questionnaire for those looking to get their AI algorithm FDA cleared. It covers topics such as validat...
Yujan Shrestha
ArticleAI/ML
This article outlines the challenges of bringing radiology AI/ML to market, from clinical workflow to IT installation. It provi...
J. David Giese
GuidanceAI/ML
FDA's Draft PCCP (Predetermined Change Control Plan) guidance should streamline model changes AI/ML-enabled devices, allowing f...
VideoAI/ML
This webinar covers the four phases of the regulatory process: Explore, Develop, Validate, and Document. It also discusses the ...
Yujan Shrestha
GuidanceAI/ML
This FDA guidance applies to AI/ML-enabled radiology software that assists in the detection of disease. Many of the principles ...
GuidanceAI/ML
This guidance is describes FDA’s thoughts on evaluating the performance of CADe radiological devices. Designing standalone and ...
GuidanceAI/ML
This document outlines the technical performance assessment required for premarket submissions of quantitative imaging devices ...
GuidanceAI/ML
Introduces standardized terms and definitions to foster a consistent understanding across the industry for ML-enabled devices.
ArticleAI/ML
This article outlines Innolitics' process for developing machine learning algorithms for FDA-cleared medical devices. It covers...
Yujan Shrestha & Grace Adams
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