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.

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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.

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AI in the EHR
AI in the EHR

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

By Jaimon Jose

MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Jaimon Jose, senior director of engineering and compliance at CharmHealth, is a software architect and technical leader with more than 18 years of product development experience in the areas of identity and security technologies, distributed systems, cloud security, and data…

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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.

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The Healthcare Burnout Backlash (pt 4): Why Contract Negotiation Has Become a Core Strategic Skill for Healthcare Administrators

By Melissa Corneal

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, legal counsel, or executive leadership, with operations stepping in afterward to execute against decisions that have already been made, but that model is evolving as healthcare delivery becomes more interconnected and operationally complex, requiring administrators to engage earlier in the process, not only to understand what is being agreed to but to help define how those agreements will function in real-world environments.

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The Healthcare Burnout Backlash (pt 3): How Workflow Redesign Is Helping Healthcare Organizations Offset Staffing Shortages

By Melissa Corneal

As organizations introduce additional technologies, including AI-enabled tools and CRM platforms, these gaps become more pronounced. Those that are seeing meaningful improvements are taking an end-to-end view, evaluating how systems interact within a unified workflow and ensuring that data flows seamlessly and actions are triggered in a coordinated manner, thereby reducing the need for manual intervention and follow-up.

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How Rural Health Systems Are Advancing Cardiac Imaging

By Dr. Joseph Cardenas, Dr. Khidir Osman MD, FACC

Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are increasingly looking to cardiac CT to redefine how advanced imaging can be delivered closer to where patients live.

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