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Innolitics

innolitics.com

Hand us the clinical data and the regulatory goal. We handle the engineering, AI/ML, QMS, V&V, cybersecurity, and submission. One team, one timeline…

Software / engineering practiceAI / MLSecurity

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193 from 11 Mar 1997 to 25 Oct 2026
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2026 59

  1. When a Software Update Needs a New 510(k): Notes from a Coffee and Q&A on FDA's Warning Letter to O.N. Diagnostics
  2. How I Think Autonomous Generative AI Medical Devices Will Be Regulated: My Public Comment to FDA
  3. Ai ml
  4. Regulatory
  5. FDA's Generative AI Discussion Paper: Notes from a Coffee and Q&A on Risk Tiers, Patient-Facing Devices, and the Premarket-Postmarket Trade
  6. September 2026 AI/ML FDA Clearances: A Close Reading of the Released 510(k) Summaries
  7. News
  8. Notes from the September 25th CDRH MDIC Regulatory Science Meeting
  9. Your AI Can Do Five Things. Which Should You Take to FDA First?
  10. Public Comment on FDA's Generative AI Device Questions: A Running Census of Docket FDA-2026-N-7874
  11. Everything Outside the Binary Is a Guess. Stop Submitting Guesses.
  12. Software
  13. Cybersecurity
  14. HD95 for Medical Image Segmentation: How to set FDA acceptance criteria and sample size
  15. De Novo Requests for Diagnostic Devices: FAQs and Examples
  16. The Predicate Ships Hardware. You Don't Have To.
  17. Early Lessons on What It Takes to Get a Generative AI-Enabled Medical Device Past FDA
  18. FDA Pre-Subs: Best Practices, FAQs, and Examples
  19. Is my software a medical device?
  20. Medical Device Cybersecurity: Best Practices, FAQs, and Examples
  21. The De Novo Pays the Toll: How Sample Size Shrinks Across AI Device Generations
  22. How Many People Should I Hire? An AI Medical Device Perspective.
  23. FDA Releases Generative AI Medical Device Discussion Paper: What's Inside
  24. How Far Can a 510(k) Predicate Stretch?
  25. How many cases to power an AUC analysis?
  26. What FDA Reviewers Will Ask About Your Sensitivity/Specificity Sample Size
  27. Cadence Enters TEMPO: What the Second Participant Suggests About the Pilot’s Direction
  28. How TEMPO and ACCESS Could Support Wearable Diagnostic AI
  29. A note too far. When a letter to file gets a warning letter instead.
  30. PCCPs: Best Practices, FAQs, and Examples
  31. CMS Is Reopening the Boundary Between AI Medical-Device Software and Clinical Laboratories
  32. What Should an FDA AI Model Description Include?
  33. How to Read an FDA Guidance Document
  34. Can AI Replace a Consultant? We Built a 1,200-Question Benchmark to Find Out.
  35. MDUFA VI vs. MDUFA V: The Side-by-Side Every Regulatory Lead Should Read
  36. Q2 2026 AI/ML FDA Clearances and De Novos
  37. First FDA-Cleared AI Agent and LLM Enabled Device Confirmed
  38. SaMD Fund-Raising: Best Practices, FAQs, and Examples
  39. AI in the Pathology Lab: How FDA is Clearing WSI Algorithms- Four Submissions, One Emerging Playbook
  40. How much money should an AI SaMD company raise?
  41. April 2026: 26 AI FDA 510(k) and One De Novo
  42. How much will an FDA clearance cost?
  43. March 2026: 24 AI/ML SaMD Clearances in 31 Days
  44. Foundation Models in AI SaMD: A Snapshot
  45. The First AI Otoscope: What TytoCare's De Novo Means for AI in ENT
  46. AI/ML in Digital Pathology and the Software-as-an-IVD Paradigm: 2026 Snapshot
  47. How to Get Your AI-Generated, Vibe-Coded Medical Device FDA-Cleared
  48. Cardiology AI: Signals Over Pixels
  49. Why We Revisit Our Mission and Values Every Year
  50. Does FDA Require Software Escrow?
  51. US Senate Mandates New Tailwinds for AI/ML Enabled Medical Devices
  52. What FDA Reviewers Will Ask About Your Bland-Altman Sample Size
  53. How to Get Your Gen AI Device to Market Without Burning Your Runway. Lessons from Kintsugi, Pear, Woebot, and Akili.
  54. 2026 FDA Guidance - Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
  55. 2026 FDA Guidance - Clinical Decision Support Software
  56. Analysis of Cuffless Non-invasive Blood Pressure Measuring Devices Guidance – Clinical Performance Testing and Evaluation
  57. Frustrated with Slow AI Adoption? Here’s why.
  58. 2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
  59. 2026 Clinical Decision Support and General Wellness Guidance Updates

2025 33

  1. Analysis of 510(k) Summary: K232613 CT Cardiomegaly
  2. AI/ML Medical Device FDA Clearances Week 52 2025
  3. The Dental AI Revolution: A Comprehensive Analysis of 510(k) Clearances (2021-2025)
  4. Diabeloop’s FDA Clearance: The SiMD to SaMD Transformation Case Study
  5. How to Build a Medical-Device Timeline You Can Actually Trust
  6. Analysis of 510(k) Summary: K252086 - DTX Studio Assist
  7. Weekly AI/ML 510(k)s, De Novos, and BDDs for December 14 to 20
  8. 2025 Year in Review: AI/ML Medical Device 510(k) Clearances
  9. 2025 FDA Guidance - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  10. Analysis of K252366 a2z-Unified-Triage
  11. Stop Doing the “Consultant Thing” and Stop Saying “Ideally”
  12. Why you need a Breakthrough Device Designation
  13. Bland Altman Analysis: Best Practices, FAQs, and Examples
  14. Reference Guide for Testing Expectations for AI/ML-Enabled SaMD
  15. System Items vs. Code Implementation: What FDA Actually Expects
  16. What Your First 510(k) Actually Costs You
  17. Additional Conditions for Non-Prescription Use: FAQs and Examples
  18. Definitive Guide to AI/ML SaMD Acceptance Criteria
  19. How to Plan MRMC and Standalone Studies for a 3-Month 510(k)
  20. Unresolved Anomalies: Best Practices, FAQs, and Examples
  21. Definitive Guide to AI/ML SaMD Ground Truthing
  22. Medical Imaging AI/ML Engineering Guide: Best Practices and Examples
  23. Design Inputs: Best Practices, FAQs, and Examples
  24. FDA’s Breakthrough Device and STeP Programs: FAQs
  25. Command Line as a Medical Device (CLaMD)
  26. Quality Work Doesn’t Mean Quality Service
  27. On Sharing SBOMs
  28. 2025 FDA Guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies
  29. 10x Coffee Talk: Review of FDA's Latest Draft AI Guidance
  30. 10x Coffee Talk: Image Processing Toolbelt
  31. Medical Device SBOMs: Best Practices, FAQs, and Examples
  32. 2025 FDA Guidance - Premarket Approval Application Modular Review
  33. 2025 Draft FDA Guidance - Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

2024 40

  1. 10x Coffee Talk: Strategies for PCCP Implementation
  2. Clinical Performance Assessments - Presentation by Ethan Ulrich
  3. How to get AI/ML SaMD FDA cleared - Presentation by: Yujan Shrestha
  4. Medical Device Recalls - Software Related
  5. Webinar - Empowering Regulatory Affairs with AI: Challenges, Insights, and Future Vision
  6. Yujan’s RSNA Talk on AI/ML SaMD
  7. Yujan's Comments at FDA Digital Health Advisory Committee on GenAI Enabled Medical Devices
  8. 10x Coffee Talk: Generative AI and FDA Guidelines
  9. FDA Grand Rounds on Synthetic Data
  10. 10x Coffee Talk: Threat Modeling and Cybersecurity Risk Management
  11. Interop
  12. Coffee Time: Is FDA Doing a Good Job with AI?
  13. Coffee Time: Medical Device Cybersecurity Threats
  14. AI Virtual Scribes: Premarket Performance Evaluation, Risk Management, and Postmarket Performance Monitoring
  15. FDA Strategy for Foundation Models, Gen AI, LLMs, AI Scribes, and Beyond
  16. 10x Talk: Intro to Prompt Engineering
  17. Open Source Radiology Foundation Models: A Comprehensive Exploration
  18. 10x Talk: Guidance on Device Changes: When to Submit a 510(k)
  19. How To Integrate With the VA VistA PACS
  20. The Ultimate 510(k) Checklist
  21. How to Document AI/ML Algorithms in FDA Presubmissions (Q-Sub)
  22. FDA Cybersecurity Readiness Survey
  23. 2024 Draft FDA Guidance - Predetermined Change Control Plans for Medical Devices
  24. How to Avoid 14 Common FDA Cybersecurity Deficiencies
  25. SMART on FHIR: Is it a Good Fit for your Medical Device Software?
  26. Foundation Models (LLM, LAM, LVM, LxM) and FDA Clearance: Best Practices, FAQs, and Presubmission Example
  27. DICOM Part 15 Security and Medical Device Software
  28. Do You Need DICOM TLS?
  29. How to Write a Device Description for a 510(k)
  30. 510(k) Preparation Pitfalls: Best Practices, FAQs, and Examples
  31. Off-The-Shelf Software: Best Practices, FAQs, and Examples
  32. Can a Glossary Speed Up Your FDA Review?
  33. Can Your Software Diagrams Slow Down Your FDA Submission?
  34. How to Write a Medical Device User Manual
  35. User Needs vs Requirements
  36. Draft FDA Generative AI Guidance
  37. How to Avoid $100k AI/ML Mistake
  38. To Rewrite or Not: From Prototype to FDA-Compliant Software
  39. Future of Generative AI in Software Medical Devices
  40. AI/ML from Idea to FDA

2023 19

  1. Digital Therapeutics: Best Practices, FAQs, and Examples
  2. Medical-Device Software Regulations: Best Practices, FAQs, and Examples
  3. Why Are you Wasting Time Building Your Medical Device?
  4. FDA Webinar Notes: Predicate Device Selection and Use of Clinical Data
  5. 2023 Final FDA Cybersecurity Guidance - Redline
  6. How Frequently Can you Release Medical Device Software?
  7. 2023 FDA Guidance - Off-The-Shelf Software Use in Medical Devices
  8. Algorithm Performance Testing Intake Form
  9. Get to Market Faster with Software-Savvy Regulatory Experts
  10. “It’s the Workflow, Stupid” - Lessons Learned Bringing Radiology AI/ML to Market
  11. 2023 FDA Guidance - Content of Premarket Submissions for Device Software Functions
  12. eSTAR Version 3 Transcript (Non-IVD Version)
  13. Multiple Device Functions Impact on FDA Submissions
  14. 2023 FDA Guidance - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
  15. Powerful Debugging Techniques: A Real-World Example
  16. Webinar on AI/ML from Idea to FDA
  17. Can We Work on our SaMD After Submitting our 510(k)?
  18. One Way to Speed Up Software 510(k) Submissions
  19. Why Notion is the Best Traceability Tool for Medical Device Startups

2022 8

  1. Quick Introduction to User Needs and Requirements
  2. How to Grow a 10x Team with Code Reviews
  3. 2022 FDA Guidance - Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions
  4. 2022 FDA Guidance - Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
  5. 2022 FDA Guidance - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
  6. 2022 FDA Guidance - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in - Premarket Notification (510(k)) Submissions
  7. 2022 FDA Guidance - Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions
  8. IMDRF 2022 Guidance - Machine Learning-enabled Medical Devices: Key Terms and Definitions

2021 3

  1. 2021 FDA Guidance - De Novo Classification Process
  2. Fuzzing, Sanitizers, and Modern Cybersecurity Practices
  3. How We Develop AI for 510(k)-Cleared Devices

2020 3

  1. 2020 Draft FDA Guidance - Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
  2. 2020 FDA Guidance - Multiple Function Device Products: Policy and Considerations
  3. 2020 FDA Guidance Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products

2019 8

  1. 2019 FDA Guidance - Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
  2. 2019 FDA Guidance - General Wellness: Policy for Low Risk Devices
  3. 2019 FDA Guidance - Policy for Device Software Functions and Mobile Medical Applications
  4. 2019 FDA Guidance - Format for Traditional and Abbreviated 510(k)s
  5. 2019 FDA Guidance - The Abbreviated 510(k) Program
  6. 2019 FDA Guidance - The Special 510(k) Program
  7. 2019 FDA Guidance - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
  8. 2019 FDA Guidance - The Least Burdensome Provisions: Concept and Principles

2018 2

  1. 2018 FDA Guidance - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
  2. 2018 FDA Guidance - Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers

2017 5

  1. 2017 FDA Guidance - Medical Device Accessories – Describing Accessories and Classification Pathways
  2. 2017 FDA Guidance - Software as a Medical Device (SAMD): Clinical Evaluation
  3. 2017 FDA Guidance - Deciding When to Submit a 510(k) for a Software Change to an Existing Device
  4. 2017 FDA Guidance - Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies. Guidance for Industry and Food and Drug Administration Staff
  5. 2017 FDA Guidance - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

2016 3

  1. 2016 FDA Guidance - Postmarket Management of Cybersecurity in Medical Devices
  2. 2016 FDA Guidance - Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
  3. 2016 FDA Guidance - Collection of Race and Ethnicity Data in Clinical Trials

2014 3

  1. 2014 FDA Guidance - In Vitro Companion Diagnostic Devices
  2. 2014 FDA Guidance - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
  3. 2014 FDA Guidance - Types of Communication During the Review of Medical Device Submissions

2013 2

  1. 2013 FDA Guidance - Design Considerations for Pivotal Clinical Investigations for Medical Devices
  2. 2013 FDA Guidance - Medical Device Classification Product Codes

2007 1

  1. 2007 FDA Guidance - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests

2005 1

  1. 2005 FDA Guidance - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software

2002 1

  1. 2002 FDA Guidance - General Principles of Software Validation

2001 1

  1. 2001 FDA Guidance - Medical Device Patient Labeling

1997 1

  1. 1997 FDA Guidance - Design Control Guidance for Medical Device Manufacturers