PARTNER
Joined: January 1, 2012
I am a physician, software engineer, AI/ML expert, and regulatory consultant. I have been developing medical device software for 10 years. I have helped startups and Fortune 500 companies write medical grade software and secure regulatory clearance. I was born in Nepal, came to the states when I was 4, and learned to code BASIC when I was 8. I graduated with a BME degree from UT Austin and a MD degree from UT Houston. I am passionate about decreasing barriers to translating medical devices from the lab to the clinic for the benefit of patients and physicians alike.
Writing about AI/ML in medical devices, playing with my son, snowboarding, video games, playing the Ukulele
ArticleAI/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
ArticleAI/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
ArticleAI/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
ArticleAI/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
ArticleAI/ML
FDA's glossary defines foundation models as AI models trained on large, typically unlabeled datasets that are adaptable across ...
Yujan Shrestha
ArticleAI/ML
Fifty-one FDA-authorized pathology AI devices through April 2026, only seven of which are whole-slide imaging algorithms. This ...
Yujan Shrestha
ArticleAI/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
ArticleAI/ML
Why digital health companies keep dying before and after FDA authorization, the evidence-reimbursement trap strangling the sect...
Yujan Shrestha
ArticleAI/ML
AI-assisted medical device development is FDA-compliant when done right. The obstacle isn’t regulation. It’s the messy codebase...
Yujan Shrestha
ArticleAI/ML
Comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights.
Yujan Shrestha
ArticleRegulatory
Side by side differences and executive takeaways from the January 2026 updates to the FDA CDS and General Wellness updates
Yujan Shrestha
ArticleAI/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
ArticleAI/ML
A data-driven look at 2025’s AI/ML 510(k) clearances: volume, review times, SaMD share, leading specialties, top manufacturers,...
Yujan Shrestha
ArticleAI/ML
Deep dive into FDA 510(k) K252366, a2z‑Unified‑Triage, a radiology triage and notification device. Explains why the triage indi...
Yujan Shrestha
ArticleAI/ML
Breakthrough Device Designation (BDD) is a free, fast FDA program that signals serious unmet need and potential meaningful impr...
Yujan Shrestha & George Hattub
ArticleAI/ML
Setting acceptance criteria incorrectly (too high or too low) can delay your FDA submission by weeks or trigger rejection. This...
Yujan Shrestha
ArticleAI/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
ArticleAI/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
ArticleAI/ML
A practical guide for engineers new to medical imaging AI, highlighting common pitfalls—like coordinate-system errors and orien...
Yujan Shrestha
ArticleAI/ML
Ideas on how to get foundation models and generative AI FDA cleared.
Yujan Shrestha
ArticleAI/ML
Recent advancements in radiology have led to the development of foundation models integrating vision and language capabilities,...
Yujan Shrestha