AI Transparency, Benchmarking Limits, and What It Means for MedTech

MedTech Leading Voice | Issue 160

📝 From the Editor

Big News for Pet Lovers:Vet Sonotron has made it to the final four for the Coolest New Thing in NJ. Tomorrow the final round ends, so be sure to vote: manufacturingcounts.org/vote

Also, thanks again to Richard Holborow and the team at BSI Medical Devices for the invitation to join last week’s Medical Device Roadshow in Boston. It was a strong session with direct insight into current EU and UK regulatory expectations and what teams should be preparing for now.

During the event, I shared some key takeaways from the roadshow, including timelines, EUDAMED readiness, and where regulatory pressure is building this year.

— Sean Smith

🧠 Featured Post

2026 AI Index Report — Transparency, Benchmarking Limits, and Capability Shifts

Danny Van Roijen summarized the 2026 AI Index Report, highlighting reduced transparency, benchmarking limitations, and continued expansion of AI capabilities.

The report shows increasing difficulty comparing models, limited visibility into training data and methods, and ongoing acceleration across core performance areas.

For MedTech teams, these shifts affect how AI systems are evaluated, validated, and governed in regulated environments. View the post >>

📌 This Week’s Top Posts (In no special order)

• The 2026 AI Index report on transparency, benchmarking limits, and evolving AI capabilities summarized by Danny Van Roijen.
• Sigrid Berge van Rooijen outlined GenAI risk considerations across implementation stages in healthcare
• Stefano Bolletta highlighted upcoming IVDR deadlines for Class C IVDs and the need for early Notified Body engagement to maintain market access.
• In her weekly Monday News, Marina Daineko covered key MDR, MHRA, FDA, and AI updates shaping MedTech. 
• EU MDR Compliance broke down common UDI special cases across device types, from implantables to SaMD and kits.
• Six common CAPA management mistakes based on patterns across hundreds of cases, underlined by Georg Digel. 
• Key updates to EU Article 10a Q&A Rev.2 and their impact on supply interruption processes detailed by Tibor Zechmeister.
• Flavio Angei announced a new IMDRF draft on AI lifecycle management regarding expanded risk and monitoring expectations.
• In his recent article, Raghbir Bhullar discussed hidden QMS risks in medical device acquisitions and gaps in traditional due diligence.
• Mario Gabrielli Cossellu shared updates on EUDAMED rollout timelines and upcoming training sessions ahead of mandatory module use.
• Zhaohui Su overviewed the FDA’s latest RWE report, highlighting its growing role in regulatory decisions and AI/ML validation.
• David Filmore on the tentative MDUFA VI agreement and projected user fee changes starting in FY 2028
• BSI Medical Devices on Team-NB’s response to proposed MDR/IVDR amendments
• Angelina Lisandrelli on PMDA updates to medical device standards, including expanded ISO/IEC recognition, SaMD expectations, and QMS alignment requirements

🎯 Featured Event

RAPS Euro Convergence 2026 — Lisbon

I am still hoping to attend RAPS Euro Convergence, which takes place May 5–8 in Lisbon, bringing together regulatory professionals across devices, IVDs, pharma, and digital health. The program focuses on EU regulatory developments, implementation challenges, and practical approaches to compliance through sessions, workshops, and peer exchange.

Register Now >>

🗓️ Upcoming Events & Webinars

• April 24, 2026 | 11:00 AM ET - AI/ML FDA Submissions: Common Pitfalls, Hard Lessons, and Faster Paths Forward,Featuring Leon Doorn, MedQAIR. A practical look at where AI submissions slow down and how to avoid avoidable delays.
• April 30, 2026 | 12:00 PM ET - Why MedTech Launches Stall: Aligning Regulatory, Reimbursement, and Commercial Strategy Earlier, featuring Michelle Lott, Renae Franz, and Fernanda Nusbaum.
• May 1, 2026 | 11:00 AM ET - EUDAMED Is Coming Fast: How to Turn Existing Documentation into Submission-Ready Files, featuring Sam Patton from EUDAPrep. Focused on taking existing documentation and preparing it for EUDAMED without rebuilding from scratch.
• May 8, 2026 | 11:00 AM ET - First-in-Human Clinical Trials in Latin America, featuring Julio G. Martinez-Clark, CEO of bioaccess®: Fast-Tracking First-in-Human Trials.
• May 15, 2026 | 11:00 AM - The QMS conversation your clients are having without you, featuring Charles Rollet, CEO at TraceX.

💥 Weekly 510(k) Roundup.

April 13, 2026 | From Marcus Engineering, LLC

44 total clearances this week across multiple categories, including 14 first-time clearances (🚀).

Featured first-time clearances:

• 🚀 Belkin Vision (MyAlcon) – Voyager DSLT: Designed to automate key steps in glaucoma laser treatment, improving consistency and reducing variability in outcomes tied to alignment and technique.
• 🚀 InnovaCorium – IWD-Gel™: Supports wound healing by improving conditions for tissue repair, reflecting continued movement toward therapies that enhance standard care.
• 🚀 Anumana, Inc. – ECG-AI Cardiac Amyloidosis Algorithm: Uses standard ECG data to flag potential signs of cardiac amyloidosis, enabling earlier detection within existing clinical workflows.

Full breakdown available in the April 13, 510(k) Roundup.

📋 Regulatory Roundup

April 13, 2026 | By Martin King

Regulators across the FDA, EMA, MHRA, and other global authorities continue to advance lifecycle-based oversight, with a stronger emphasis on practical implementation, digital systems, and post-market control.

This week’s updates reinforce continuous lifecycle regulation, expanding digital infrastructure such as EUDAMED and CTIS, tightening post-market surveillance expectations, and accelerating AI oversight through lifecycle controls and monitoring requirements.

Growing reliance on real-world evidence, increasing global convergence through IMDRF and WHO frameworks, and heightened focus on operational resilience and supply chain risk are shaping how manufacturers plan and execute across markets.

Explore the update >>

🔥 Postscript

IMSC26 – International MedTech Safety Conference 2026

Join me, June 2–5, 2026 | Boston - IMSC26, featuring Dr. Michelle Tarver, FDA Director of CDRH, and a host of expert speakers. IMSC26 brings together MedTech professionals, regulators, and technical experts focused on safety, risk, and AI. Virtual or In-person.

Special MLV Discount Codes:

• $200 off General Registration (in-person OR virtual): MLV$200
• Startup: Start$250 – $250 off in-person registration
• Startup Education Day: StartEd$50 – $50 off

Register Now >>

Sean 🐝