PARTNER
Joined: January 1, 2012
I have led or supported FDA strategy and submissions for 51+ medical devices, most AI-enabled, since co-founding Innolitics in 2012, across 510(k), De Novo, Breakthrough, Q-Sub, and deficiency responses. My work spans radiology AI (CADe, CADx, CADt, quantitative imaging), cardiac and neuro imaging software, dental AI, LLM and foundation model devices, and I have managed or contributed to 65 Innolitics projects. FDA's public clearance letters for AI Metrics (K202229, 2020) and Medweb's Lightning Viewer (K242362, 2024) name me as the sponsor's correspondent. I presented at FDA's first Digital Health Advisory Committee meeting on generative AI in November 2024, I have published 78 articles on innolitics.com, and I built fda.innolitics.com, our public FDA device search tool.
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
The myth: a real-time or in-procedure indication needs a hardware device. We screened all 1,483 AI/ML-flagged FDA records and found 50 verified clearances where software-only de...
Yujan Shrestha
ArticleAI/ML
FDA's Aug 18, 2026 discussion paper proposes grading generative AI medical devices like physicians: benchmarks, then clinical confirmation, then live monitoring. What it says, w...
Yujan Shrestha
ArticleAI/ML
Can a frontier AI model replace your FDA regulatory consultant? We built a private 1,200-question benchmark, an opinionated distillation of 15 years of consulting judgment, and ...
Yujan Shrestha
ArticleAI/ML
FDA authorized 86 AI/ML devices in Q2 2026, but the sharper signal came after first clearance: 12 Special 510(k)s, 12 PCCPs, two new De Novo categories, and route choices that c...
Yujan Shrestha
ArticleAI/ML
FDA's draft MDUFA VI commitment letter (FY2028–2032) restructures how sponsors interact with the agency. Seven changes that will reshape submission planning for software and AI ...
Yujan Shrestha
ArticleAI/ML
UpDoc is now the clearest public example of an FDA-cleared LLM-enabled medical device. Here's what FDA actually cleared, why the clinical decision still sits behind a determinis...
Yujan Shrestha
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 market-comparable median, $11.0M capital-efficient, 2...
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 (DEN200080), ArteraAI Prostate (DEN240068), Galen S...
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 of 35 post-IPO AI/ML SaMD clearances shows $51.2M ...
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: radiology dominance, PCCP under-adoption, the lo...
Yujan Shrestha
ArticleAI/ML
FDA's glossary defines foundation models as AI models trained on large, typically unlabeled datasets that are adaptable across a wide range of contexts via fine-tuning, built on...
Yujan Shrestha
ArticleAI/ML
Fifty-one FDA-authorized pathology AI devices through April 2026, only seven of which are whole-slide imaging algorithms. This snapshot separates the hematology-analyzer volume ...
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 about the future of FDA-cleared software.
Yujan Shrestha
ArticleAI/ML
Why digital health companies keep dying before and after FDA authorization, the evidence-reimbursement trap strangling the sector, and a post-market-first framework for breaking...
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 you’ve been ignoring.
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 duopoly controlling 34% of the market, the 172-day FD...
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, and early PCCP adoption.
Yujan Shrestha
ArticleAI/ML
Deep dive into FDA 510(k) K252366, a2z‑Unified‑Triage, a radiology triage and notification device. Explains why the triage indication is likely the best way to get foundation mo...
Yujan Shrestha
ArticleAI/ML
Breakthrough Device Designation (BDD) is a free, fast FDA program that signals serious unmet need and potential meaningful improvement. For AI/ML SaMD teams, it de-risks pivotal...
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 guide analyzed 784 AI/ML medical device clearance...
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 while continuously accruing standalone evidence thro...
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 strategies specifically.
Yujan Shrestha
ArticleAI/ML
A practical guide for engineers new to medical imaging AI, highlighting common pitfalls—like coordinate-system errors and orientation mix-ups—and providing simple checks to avoi...
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, transforming medical imaging analysis
Yujan Shrestha
