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Digital Health


Featured Articles

August 20, 2026

AI-Assisted Triage: Accelerating Post-Market Surveillance While Eliminating Reporting Blind Spots

By Binitkumar M. Vaghani

Complaint volumes have outgrown manual triage, and medical device companies are turning to AI to keep up. The speed gains are real, but used carelessly the same tools can bury a reportable event at the bottom of a queue while the MDR clock runs. This piece maps where AI genuinely helps in post-market surveillance, where human judgment has to stay, and what validation, monitoring, and audit trails a defensible program needs. It is grounded in the current regulatory frame, including the QMSR and FDA's new inspection program (CP 7382.850) that took effect February 2, 2026, 21 CFR Part 803 reporting timelines, and ISO 13485 software validation expectations. It includes a practical table drawing the line between tasks that are safe to automate and decisions that must stay human-owned. The intended audience is quality, regulatory, and post-market surveillance professionals in the medical device industry.

August 19, 2026

Sensors at the Edge: Powering Smarter Healthcare

By Daraius Patell

As healthcare shifts towards remote monitoring, connected devices and decentralized care, sensor technologies are becoming increasingly foundational to how medical devices collect, validate and transmit critical information. From remote patient monitoring and at-home care to connected medical devices and robotic-assisted surgery, sensing technologies can help enable earlier detection, more reliable clinical data and better-informed decision making.

August 18, 2026

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.  

August 3, 2026
SaMD Readiness

Beyond the Status Report: Using LLMs to Reveal the True State of SaMD Development

By Shreya Sridhar

Medical device software development teams have always struggled with a deceptively simple question: How much of the system is actually complete?

June 29, 2026
AI Compliance in Medical Devices

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Anthony Watson, Geethapriya (Priya) Setty, Jay Vaishnav, PhD

By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.

June 1, 2026

MedTech In Focus: AI impact in healthcare

By MedTech Intelligence Staff

The most recent AI thought leadership published on MedTechIntelligence.com.

May 20, 2026
Justice scale, healthcare, cost

Value, Focus, and the Future of MedTech: M&A and Divestitures are Rewriting the Strategic Playbook.

By Joan Hinrichs

Market Access is now the central input into M&A and value-driven divestitures, enabling MedTech leaders to reshape portfolios for strategic advantage, long-term growth, and greater value to patients - unlocking their full potential.

May 20, 2026

The Boston Children’s Experience: Hidden ICU Risk and AI-Driven De-escalation

By Evan Butler

Boston Children’s Hospital physicians say one of the greatest risks in pediatric ICUs is delayed de-escalation of care, which can expose children to prolonged ventilation, sedation, and vasoactive medications. They argue that AI-driven clinical intelligence can help clinicians identify safer timing for weaning and extubation, supporting recovery and improving long-term outcomes.

May 11, 2026
Field Service Technology

The Hidden Design Flaw in Medical Device Service Technology

By Ryan Condon

Health systems globally face higher utilization, tighter scrutiny, and less operational slack. As devices become more connected and service events more consequential, the limitations of generic service technology become harder to ignore.

May 11, 2026
Data protection, intelliectual property, medtech

The Medical Device Cybersecurity Gap Hiding in Plain Sight

By Partha Anbil, Saravanan Manikandan

In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.

View More Digital Health Articles »

News & Views

  • The Interface is the Risk: A MedTech Blueprint for AI and System Integration

  • Zimmer Biomet to Hire 500 in India as New Bengaluru Technology Centre Drives AI and MedTech Innovation

  • AdaptHealth Investigates Data Breach After Social Engineering Attack, Possible Link to ShinyHunters Emerges

  • Applying Agentic AI to Healthcare Delivery: The Key to True Transformation

  • Signatera CDx Gets FDA Nod as Companion Diagnostic for Muscle-Invasive Bladder Cancer

  • FDA Expands AI Capabilities: Launches ELSA and Completes HALO Data Platform Consolidation

  • Why Gen AI is a Win for MedTech: And, How to Unlock its Potential with the Right Policies

  • Interoperability was Never the Finish Line in Healthcare

  • FDA Publishes New Set of Real-World Evidence Examples

  • CDRH Guidance: Patient Preference Information (PPI) in Medical Device Decision Making

Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle


On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery





TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle

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