FDA-Authorized AI-Enabled Medical Devices: An Updated Report

In this Issue

From the Editor ✍🏽 | In Brief 💥 | Featured Post 📌 | Sections ✅ | Postscript 🐝

From the Editor ✍🏽

🔥 Featured Post: Margaretta Colangelo shared a new analysis on the FDA's newly published list of 1247 authorized AI-enabled medical devices.

📌 And 12 more super-useful new posts, Martin King’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC.

🚀 Featured Webinar

Proactive CAPA Systems: From Compliance to Prevention

📅 Thursday, July 24 | 10 AM ET | Live on Zoom | Register here

Is your CAPA system solving problems—or just satisfying auditors?

Join MLV and AKRA TEAM for a sharp, practical session on making CAPA a real tool for improvement. Featuring subject matter experts Azam Khorshidi (DEKRA), Zaher Kharboutly (DNV), and Anna Spehl (AKRA TEAM).

Topics include:

• Root cause analysis that actually works
• CAPA strategies to prevent repeat issues
• How to avoid common audit findings
• And more...

All registrants will receive the recording. Register Now

In Brief 💥

In no special order...

• Dr. Pallavi Dasgupta shared a helpful infographic of the proposed UDI extension, spotlighting smarter data integration, faster labeling updates, and stronger traceability before EUDAMED goes live.
• Marina Daineko outlined four essential criteria for selecting a biocompatibility expert, stressing the importance of technical proficiency, regulatory knowledge, communication skills, and project availability.
• EU MDR Compliance broke down the 7 core pillars of Technical Documentation, underscoring its role as a structured, interconnected system that proves MDR conformity.
• 18 key CAPA terms were outlined by Georg Digel to help med device teams focus on root causes over surface-level symptoms.
• Tibor Zechmeister outlined Four AI validation strategies for MedTech leaders to apply to ensure safe, compliant innovation.
• In a helpful video by Beat Keller, he detailed how poor traceability and missing structure can lead to delays in market access and driving up recall expenses. 
• Jose Bohorquez shared practical ways to organize cybersecurity traceability, so FDA reviewers can follow the story and spot gaps before they become deficiency letters.
• AI-powered regulatory monitoring was detailed by Bastian Krapinger-Ruether as a scalable alternative to manual tracking, offering device-specific insights mapped directly to technical files.
• The FDA’s addition of a public list of sensor-based digital health technologies (sDHTs) was explored by Jennifer Goldsack. to underscore how regulatory clarity, existing endpoint alignment, and ROI modeling can accelerate digital endpoints in clinical trials.
• Michelle Lott detailed key pitfalls that derail early-stage medical device commercialization such as misaligned regulatory pathways and late-stage quality systems.
• The wellness–medical device boundary was examined by Alex G. Lee, who argued that user experience and functionality are now driving factors of FDA oversight of adaptive, AI-powered health tools.
• Delphine Le Grand discussed the FDA’s warning letter to WHOOP over its Blood Pressure Insights feature, framing it as a signal that wellness tech is increasingly being treated as regulated medical care.

🔥 Martin King broke it down step-by-step, showing exactly how AI can generate ISO 13485-aligned FMEAs and speed up sealing process validation.

📌 Featured Post: 1,247 FDA-Authorized AI-Enabled Medical Devices—and Counting

This week, Margaretta Colangelo and Lambert Leong released a major update to one of the most closely watched datasets in MedTech: the FDA’s running list of AI-enabled medical devices.

Since 1995, the FDA has authorized over 1,200 AI-enabled devices via 510(k), De Novo, or PMA. The latest update includes 297 new authorizations since August 2024, bringing the total to 457 companies with AI devices on the market.

The latest edition of their newsletter, AI in Healthcare Milestones, features 12 new charts that visualize how AI is reshaping radiology (with 956 devices), cardiology, neurology, ophthalmology, and more. Big names like GE, Siemens, Philips, and Aidoc dominate the approvals list, but new players are emerging fast.

What’s next? The FDA is now developing tagging methods to flag LLM-based functionality inside medical devices. Foundation models are about to enter the clinical conversation.

👉 Read the full breakdown, visualizations, and analysis in the original post by Margaretta and Lambert.

Sections ✅

Regulatory Roundup by Martin King - July 14, 2025

📌 ANVISA Brazil📌 Egyptian Drug Authority📌 European Commission📌 European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe📌 European Medicines Agency📌 ISO - International Organization for Standardization📌 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗖𝗼𝘂𝗻𝗰𝗶𝗹 𝗳𝗼𝗿 𝗛𝗮𝗿𝗺𝗼𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻📌 Health Sciences Authority (HSA), Singapore📌 Medicines and Healthcare products Regulatory Agency📌 Swissmedic📌 Therapeutic Goods Administration (TGA), Australia📌 FDA USA Food & Drug Administration📌 World Health Organization

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✅ 510(k)s at a Glance for the week of July 14, 2025

Marcus Engineering, LLC highlighted 63 new FDA 510(k) cleared devices last week.

👉 For full details, visit Marcus Engineering’s report.

🗓️ What’s Happening

July 24 (10 am ET): Proactive CAPA Systems: From Compliance to Prevention. Featuring subject matter experts Azam Khorshidi (DEKRA), Zaher Kharboutly (DNV), and Anna Spehl (AKRA TEAM).

July 25 (11 am ET): MLV Friday In-Focus Call, featuring Jose Bohorquez, presenting "FDA 510(k) Cybersecurity Compliance."

🔥 Sept 3-4, Munich: Accelerate Your Quality Career! Join 17 subject matter experts for 2 days of immersive learning at the new Quality Accelerator Program by AKRA TEAM.

Postscript 🐝

I am looking forward to attending the TEAM-PRRC Annual Summit in Rome on October 23-24. Early-bird discount ends soon. Join me and Daniela Karrer on Oct. 22 for a free Caravaggio walking tour.