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September 29, 2026

CPT 2027 Adds Ten AI Service Codes: What the AMA Release Means for AI/ML Device Developers

Medical device

Regulatory

Cybersecurity

September 29, 2026

NIST Cybersecurity Resource Guide

Medical device

Quality

Software

V&V

September 29, 2026

FDA Update on Computer Software Assurance for Production and Quality System Software

Machine Learning

FDA

Regulatory

Medical device

September 29, 2026

AI in Mammography Screening: What a New Meta-Analysis of FDA-Cleared and CE-Marked Systems Shows

Regulatory

Medical device

SaMD

Europe

September 29, 2026

Zero-distance XR Applications and Services: What the European Commission's XR Landscape Report Means for Health XR Developers

FDA

Regulatory

Machine Learning

SaMD

September 29, 2026

ARPA-H ADVOCATE: The First Bid for FDA-Authorized Autonomous Clinical AI and What It Means for Developers

Regulatory

Machine Learning

SaMD

Medical device

September 29, 2026

The UK National Commission on AI in Healthcare: What Its Recommendations Mean for AI Device Developers

Regulatory

Machine Learning

Medical device

SaMD

September 29, 2026

Governing Neuro-AI: What the EGE's Infrastructure Approach Means for Neurotech and AI Device Developers

Machine Learning

Medical device

SaMD

Strategy

September 29, 2026

NSF's State and Regional AI Infrastructure Hubs: What They Mean for Medtech AI Developers

FDA

Regulatory

Medical device

Usability

Quality

September 29, 2026

FDA Updates Its Human Factors Guidance: What Changed and What It Means for Device Developers

FDA

Regulatory

Machine Learning

SaMD

September 29, 2026

PRIMED-AI: What NIH's New Funding Program Means for Multimodal AI Developers

FDA

Regulatory

Medical device

SaMD

September 29, 2026

The FDA at 120: What 120 Years of Regulatory History Means for SaMD, AI, and XR Developers

Europe

Machine Learning

SaMD

Quality

September 29, 2026

EN 18286 Passes the Formal Vote: What the First EU AI Act QMS Standard Means for AI/ML Device Makers

Regulatory

Europe

Medical device

SaMD

September 29, 2026

The EU AI Act's New Timeline: What the Digital Omnibus Means for AI-Enabled Medical Devices

Regulatory

Machine Learning

SaMD

Medical device

September 29, 2026

IMDRF's Draft N93 Technical Framework: What AI Device Makers Need to Know

Regulatory

Medical device

SaMD

Europe

Strategy

September 29, 2026

The UK's Regulatory Reset: What MHRA's 2026 Reforms Mean for Medtech

FDA

Regulatory

Medical device

Quality

SaMD

September 29, 2026

NEST Mark: Real-World Data Source. What Device Teams Need to Know

Cybersecurity

FDA

Regulatory

Medical device

SaMD

September 29, 2026

Validating Medical Device Cybersecurity Through Penetration Testing: What MDIC's New Best Practices Mean for Developers

FDA

Regulatory

Machine Learning

Medical device

September 29, 2026

Validating AI Segmentation Without a Gold Standard: A New FDA Method and What It Means for Developers

FDA

Regulatory

Medical device

Usability

Quality

September 29, 2026

FDA Finalizes Human Factors Content Guidance for Marketing Submissions: What It Means and Why It Matters

Cybersecurity

Machine Learning

SaMD

Regulatory

September 29, 2026

MITRE's April 2026 Medical Device Cybersecurity Papers: What SaMD Teams Need to Know

Regulatory

SaMD

Medical device

Europe

September 29, 2026

New MHRA Guidance for Digital Mental Health Technologies

Machine Learning

Medical device

Regulatory

SaMD

September 29, 2026

Understanding IMDRF's Final Guidance: Implications for Medical Device Developers

Medical device

SaMD

Product Development

Quality

Software

September 29, 2026

Designing Your Software Medical Device (SaMD) Verification and Validation Plan, Protocol, and Report

Regulatory

Strategy

Medical device

Product Development

September 29, 2026

AI in Healthcare: Key Takeaways from the 2025 HHS AI Strategic Plan

Medical device

Product Development

SaMD

Regulatory

Strategy

September 29, 2026

How to create a Threat Model and Vulnerability Assessment to comply with FDA cybersecurity expectations.

Cybersecurity

Product Development

Medical device

Regulatory

Quality

September 29, 2026

Summary of FDA Cybersecurity Guidance for Medical Devices

Regulatory

Europe

AI Act

September 29, 2026

EU AI Act: Key Deadlines and Article 5 Compliance Explained

Machine Learning

Medical device

Product Development

Quality

September 29, 2026

Navigating the AI Lifecycle Management Model: A Playbook for Medical Device Developers

Medical device

Product Development

Regulatory

Template

Guide

September 29, 2026

Human Factors Validation for Medical Devices

Regulatory

Product Development

Quality

Medical device

September 29, 2026

Unlocking the Future of AI in Radiology with A new FDA-QUALIFIED Tool

Regulatory

Product Development

Quality

Strategy

September 29, 2026

Leveraging Computational Modeling for Medical Device Premarket Submissions: A Comprehensive Guide

Machine Learning

Regulatory

AI Act

September 29, 2026

Understanding the EU AI Act's Transparency Requirements for General-Purpose AI

Machine Learning

Product Development

Quality

Regulatory

SaMD

September 29, 2026

FDA, MHRA, Health Canada AI Update: Transparency Princples for Machine Learning-Enabled Medical Devices

Machine Learning

Medical device

Product Development

Quality

Regulatory

September 29, 2026

Understanding Data Drift in Medical Machine Learning: A Guide for AI/ML Developers

Medical device

Quality

SaMD

Template

September 29, 2026

How to prepare your quality system for commercialization

Regulatory

Product Development

Medical device

September 29, 2026

AI and ML in Radiology and Regulatory Frameworks

Medical device

SaMD

Quality

September 29, 2026

Introducing Digital QMS Toolkits for SaMD Startups

Regulatory

Machine Learning

Medical device

Strategy

September 29, 2026

What is an FDA Predetermined Change Control Plan (PCCP) and how to create one for your AI/ML product

Medical device

Regulatory

Product Development

Risk Management

September 29, 2026

Navigating Risk Management for AI/ML Medical Devices

Regulatory

Strategy

September 29, 2026

FDA Demystifies AI/ML devices for Product Development

Medical device

Regulatory

September 29, 2026

The Promise and Peril of Large Language Models for Global Health

Medical device

Regulatory

September 29, 2026

Explore key EU MDR updates and strategies for effective clinical evaluations

Medical device

Regulatory

September 29, 2026

FDA Perspective on Prioritization software vs Triage Software

Cybersecurity

Medical device

Regulatory

September 29, 2026

Unveiling AAMI SW96: A New Era for Medical Device Cybersecurity Standards

Medical device

Regulatory

Strategy

September 29, 2026

FDA's Breakthrough Devices Program Update October 2023

Medical device

Regulatory

Strategy

September 29, 2026

Regulations for AI/ML-enabled Medical Devices in US and EU

Medical device

Product Development

Regulatory

Strategy

September 29, 2026

Overview of the UK’s New Approach to AI

Medical device

Regulatory

Strategy

September 29, 2026

FDA Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

Regulatory

Medical device

AI Act

September 29, 2026

EU AI Act Impact on Medical Devices

Medical device

Regulatory

Strategy

September 29, 2026

FDA Clinical Decision Support Update

Medical device

Regulatory

September 29, 2026

FDA Breakthrough Device Update

Medical device

Regulatory

September 29, 2026

FDA Medical Device Regulations Overview

Regulatory

Medical device

September 29, 2026

FDA Regulatory Framework Overview for Promotion of Medical Devices

Medical device

Regulatory

Strategy

September 29, 2026

FDA Review Process for 510(k)

Regulatory

Medical device

FDA

Strategy

September 29, 2026

A Crash Course in the De Novo Program: What Device Developers Need to Know in 2026

Product Development

September 29, 2026

Why it’s time to transition from outputs to outcomes

Content Marketing

SEO

September 29, 2026

User-friendly content with SEO best practices

Marketing

Branding

September 29, 2026

Nailing the Basics: What is Branding?

Regulatory

Medical device

September 29, 2026

What is an FDA Pre-Submission?

Marketing

September 29, 2026

The Emotional State of Consumers during COVID-19

Regulatory

September 29, 2026

FDA Guidance on Digital Health Devices For Treating Psychiatric Disorders during COVID-19

Marketing

Strategy

September 29, 2026

What’s the Difference between Go-To-Market and Marketing Strategies?

Regulatory

Medical device

Marketing

September 29, 2026

FDA Draft Guidances: Social Media Advertising Promotion

Medical device

September 29, 2026

How to determine if your product is a medical device

Medical device

Regulatory

September 29, 2026

FDA Resources for COVID-19

Machine Learning

Medical device

Product Development

Regulatory

June 25, 2024

Blog

Blog Archive

CPT 2027 Adds Ten AI Service Codes: What the AMA Release Means for AI/ML Device Developers

NIST Cybersecurity Resource Guide

FDA Update on Computer Software Assurance for Production and Quality System Software

AI in Mammography Screening: What a New Meta-Analysis of FDA-Cleared and CE-Marked Systems Shows

Zero-distance XR Applications and Services: What the European Commission's XR Landscape Report Means for Health XR Developers

ARPA-H ADVOCATE: The First Bid for FDA-Authorized Autonomous Clinical AI and What It Means for Developers

The UK National Commission on AI in Healthcare: What Its Recommendations Mean for AI Device Developers

Governing Neuro-AI: What the EGE's Infrastructure Approach Means for Neurotech and AI Device Developers

NSF's State and Regional AI Infrastructure Hubs: What They Mean for Medtech AI Developers

FDA Updates Its Human Factors Guidance: What Changed and What It Means for Device Developers

PRIMED-AI: What NIH's New Funding Program Means for Multimodal AI Developers

The FDA at 120: What 120 Years of Regulatory History Means for SaMD, AI, and XR Developers

EN 18286 Passes the Formal Vote: What the First EU AI Act QMS Standard Means for AI/ML Device Makers

The EU AI Act's New Timeline: What the Digital Omnibus Means for AI-Enabled Medical Devices

IMDRF's Draft N93 Technical Framework: What AI Device Makers Need to Know

The UK's Regulatory Reset: What MHRA's 2026 Reforms Mean for Medtech

NEST Mark: Real-World Data Source. What Device Teams Need to Know

Validating Medical Device Cybersecurity Through Penetration Testing: What MDIC's New Best Practices Mean for Developers

Validating AI Segmentation Without a Gold Standard: A New FDA Method and What It Means for Developers

FDA Finalizes Human Factors Content Guidance for Marketing Submissions: What It Means and Why It Matters

MITRE's April 2026 Medical Device Cybersecurity Papers: What SaMD Teams Need to Know

New MHRA Guidance for Digital Mental Health Technologies

Understanding IMDRF's Final Guidance: Implications for Medical Device Developers

Designing Your Software Medical Device (SaMD) Verification and Validation Plan, Protocol, and Report

AI in Healthcare: Key Takeaways from the 2025 HHS AI Strategic Plan

How to create a Threat Model and Vulnerability Assessment to comply with FDA cybersecurity expectations.

Summary of FDA Cybersecurity Guidance for Medical Devices

EU AI Act: Key Deadlines and Article 5 Compliance Explained

Navigating the AI Lifecycle Management Model: A Playbook for Medical Device Developers

Human Factors Validation for Medical Devices

Unlocking the Future of AI in Radiology with A new FDA-QUALIFIED Tool

Leveraging Computational Modeling for Medical Device Premarket Submissions: A Comprehensive Guide

Understanding the EU AI Act's Transparency Requirements for General-Purpose AI

FDA, MHRA, Health Canada AI Update: Transparency Princples for Machine Learning-Enabled Medical Devices

Understanding Data Drift in Medical Machine Learning: A Guide for AI/ML Developers

How to prepare your quality system for commercialization

AI and ML in Radiology and Regulatory Frameworks

Introducing Digital QMS Toolkits for SaMD Startups

What is an FDA Predetermined Change Control Plan (PCCP) and how to create one for your AI/ML product

Navigating Risk Management for AI/ML Medical Devices

FDA Demystifies AI/ML devices for Product Development

The Promise and Peril of Large Language Models for Global Health

Explore key EU MDR updates and strategies for effective clinical evaluations

FDA Perspective on Prioritization software vs Triage Software

Unveiling AAMI SW96: A New Era for Medical Device Cybersecurity Standards

FDA's Breakthrough Devices Program Update October 2023

Regulations for AI/ML-enabled Medical Devices in US and EU

Overview of the UK’s New Approach to AI

FDA Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

EU AI Act Impact on Medical Devices

FDA Clinical Decision Support Update

FDA Breakthrough Device Update

FDA Medical Device Regulations Overview

FDA Regulatory Framework Overview for Promotion of Medical Devices

FDA Review Process for 510(k)

A Crash Course in the De Novo Program: What Device Developers Need to Know in 2026

Why it’s time to transition from outputs to outcomes

User-friendly content with SEO best practices

Nailing the Basics: What is Branding?

What is an FDA Pre-Submission?

The Emotional State of Consumers during COVID-19

FDA Guidance on Digital Health Devices For Treating Psychiatric Disorders during COVID-19

What’s the Difference between Go-To-Market and Marketing Strategies?

FDA Draft Guidances: Social Media Advertising Promotion

How to determine if your product is a medical device

FDA Resources for COVID-19

FDA Greenlights Revolutionary Skin Cancer Detection Device and the Regulatory Implications for Future AI/ML-enabled devices

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