Practical tips for medical-device software engineers, process, and tips
FeaturedArticleAI/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
FeaturedArticleAI/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
FeaturedArticleAI/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
FeaturedArticleAI/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
FeaturedArticleAI/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
FeaturedArticleAI/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
FeaturedArticleRegulatory
The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article presents Innolitics’...
J. David Giese
FeaturedArticleAI/ML
Ideas on how to get foundation models and generative AI FDA cleared.
Yujan Shrestha
ArticleAI/ML
FDA publicly rejected Nihon Kohden's letter-to-file decision, so we pulled every warning letter FDA has published — 5,712 of them, 2015–2026 — classified them with AI, and mappe...
Yujan Shrestha
ArticleAI/ML
CMS and CDC are asking whether AI-assisted postanalytic interpretation, digital pathology, cloud analytics, and data-only medical-device software facilities should fall within t...
Yujan Shrestha
ArticleAI/ML
Learn how to write an FDA-ready AI model description covering inputs, outputs, architecture, training, selection, thresholds, pretrained components, limitations, and the submitt...
Yujan Shrestha
ArticleSoftware
Notes on medtech funding, covering accelerators and funding sources.
J. David Giese
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 everyone who follows. Inside the 330-day review: a new S...
Yujan Shrestha
ArticleAI/ML
From solo clinicians prototyping algorithms to enterprise teams shipping production software, tools like Cursor, Claude Code, ChatGPT Codex, GitHub Copilot, Lovable, Replit, Ant...
Yujan Shrestha
ArticleRegulatory
Are your medical device timelines slipping despite a smart team and lots of effort? This article explains Innolitics’ practical, Gantt-chart-driven approach to medical device pr...
J. David Giese
ArticleAI/ML
Most first-time teams burn over a year overbuilding documentation FDA never asks for. Here is a section-by-section breakdown of a cleared AI/ML SaMD 510(k) (Body Check CT Cardio...
Yujan Shrestha
ArticleRegulatory
To provide quality service to our clients, we need to do more than produce quality work.
J. David Giese
VideoRegulatory
The discussion in the transcript revolves around the FDA’s Draft Guidance on AI in Medical Devices, focusing on regulatory considerations, cybersecurity threats, risk mitigation...
Matt Hancock
VideoAI/ML
Kris Huang led a discussion on key image processing techniques in medical imaging, focusing on CT and MRI scans. Topics included histogram equalization, morphological operations...
Kris Huang
VideoAI/ML
Discussion covered key takeaways from the RSNA conference, balancing safety with speed, and setting risk thresholds. Topics included statistical power, U.S. data needs, AI/ML sa...
Yujan Shrestha & 2 others
VideoSoftware
The discussion outlines the evolution of FDA regulations, common violations, and the enforcement structure. It emphasizes the importance of compliance in medical device manufact...
George Hattub
VideoAI/ML
The discussion explores generative AI (GenAI) in medical devices, focusing on FDA's considerations for regulation, risks, and the lifecycle management of such technologies. Key ...
Yujan Shrestha & J. David Giese
VideoCybersecurity
We discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufacturer needs. They highlight risks like network vulne...
Yujan Shrestha & J. David Giese
VideoAI/ML
Yujan and David discussed the topic of FDA's performance in regulating AI medical devices, focusing on the ideal regulatory situation, the impact of AI on risk analysis, and the...
Yujan Shrestha & J. David Giese
VideoAI/ML
A 10x talk exploring the basics of prompt engineering, followed by an open-ended discussion.
ArticleDICOM
A practical guide for integrating software with VistA, the VA’s PACS. This guide is based on our experience working through the process with our client.
ArticleSoftware
Overview of SMART on FHIR and when it’s a good approach to integrating your software into the clinical workflow. It includes a few sequence diagrams and discusses when its an ap...
ArticleRegulatory
An in-depth guide to navigating the use of off-the-shelf software (OTS) in the medical device industry. OTS software is general purpose software you didn’t develop yourself that...
J. David Giese
ArticleCybersecurity
A short article that attempts to explain why badly made diagrams will confuse FDA reviewers and slow down your submissions. Includes links to the relevant guidance and a few bes...
J. David Giese
ArticleAI/ML
What is the difference between user needs and requirements?
Yujan Shrestha
ArticleRegulatory
This article discusses engineering and regulatory factors to consider when deciding to rewrite or reuse existing prototype code. It should be useful to researchers or companies ...
J. David Giese
ArticleRegulatory
If you’ve ever been working on a medical-device and have thought, “this is a waste of time,” this article is for you. It will provide a framework for understanding which activit...
J. David Giese
ArticleRegulatory
Medical-device software release frequency is a common question, particularly from software engineers familiar with agile development. The answer hinges on two key factors: wheth...
J. David Giese & Jim Luker
GuidanceRegulatory
This guidance document explains how medical device manufacturers can incorporate off-the-shelf software (OTS) into their devices, while still ensuring continued safe and effecti...
ArticleSoftware
This article explains why regulatory consultants who understand software can save your engineers time and help get your medical device to market faster. It also provides tips fo...
J. David Giese
VideoSoftware
Learn from a real-world Medtech OS software bug and explore various debugging techniques that can help you navigate through software issues and find solutions effectively.
J. David Giese
VideoRegulatory
What is traceability? How does Notion help you handle it? How does Notion's flexibility empower medical device startups in ways that eQMS vendors can't.
J. David Giese
VideoSoftware
This video explains why code reviews are essential for growing a 10x software engineering team and how to do code reviews well.
J. David Giese
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Get To Market Faster
Our Medtech tips will help you get safe and effective Medtech software on the market faster. We cover regulatory process, AI/ML, software, cybersecurity, interoperability and more.
