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FEATURE ARTICLE

Safety of AI in Medical Devices

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.  



FEATURED CONTENT

navigating regulatory strategy

Navigating the Global Regulatory Landscape: A Foundation for Medical Device Commercial Viability

By Partha Anbil

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent regulatory strategy required by investors.

Safety of AI in Medical Devices

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

Off-label and contraindicated medical device use

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

Balancing Cyber Risk

The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?

By Justin Kozak

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?

Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

By Randy Knotts

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

Medical Device R&D Bottleneck

R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?

By Venkatesan (Venkat) Muthukrishnan

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.

The Hidden Complexities of Medical Needle Design

By Kelly Peterson

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.

Smart Critical Care

Using AI and LLMs to fill in fragmented data gaps within complex critical care

By Dimitar Baronov, PhD

AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to deliver real-time insights. This allows for prompt escalation or de-escalation of treatment and enhances patient outcomes. These technologies also help reduce staffing issues and prevent clinician burnout by continuously monitoring patient risk and supporting decision-making in busy ICU settings.






MEDTECH VIEWPOINT

Mental Health Reimbursement

Demand for Non-Pharmacological Mental Health Needs a Delivery System

By Allan Gobbs

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to accelerate scale.

ChatGPT

How ChatGPT Health is rewriting patient engagement

By Christoph Lippuner

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. Despite this growing reliance on digital tools, the same survey revealed a disconnect in patient confidence, with almost 80% reporting that they do not feel fully in control of their healthcare. How might ChatGPT Health accelerate this shift, as well as what needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?

Superemployees - AI human evolution

How is AI Enabling Darwinian growth for Life Science Professionals?

By Ivor Campbell

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.

Artificial Intelligence Graphic

AI and Functional Precision Medicine: A Defining Moment for Pediatric Cancer Care

President Trump’s 2025 executive order establishing artificial intelligence (AI) in pediatric cancer as a national priority marks a turning point in medicine. For decades, childhood cancer treatments have advanced slowly, constrained by limited data, small clinical trials, and therapies designed for adults. The convergence of AI and Functional Precision Medicine (FPM) now offers a path to faster, more accurate, and more personalized treatments for children, one that replaces population-based best guesses with evidence-driven precision care.

ASK THE EXPERT

medtech development

Product Development Outsourcing Needs Speed, Safety & Certainty

Seek partners who can see your vision — the full picture, anticipate challenges, and help you navigate complexity with confidence.

medtech design standards

4 FAQs to Notified Bodies

Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.

Product Lifecycle Management

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

NEWS

  • MTI Regulatory Roundup: global medical device regulatory update

  • FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies

  • EndoQuest to Advance Next-Generation Surgical Robotics powered by NVIDIA IGX Thor

  • AtriCure Announces the First Patient Treated in the BoxX-NoAF Clinical Trial

  • Thermo Fisher Scientific to Acquire Clario to Provide Deeper Clinical Insights

  • Hologic to be Acquired by Blackstone and TPG for up to $79 per Share

  • AAMI and TechNation Collaborate to Survey Healthcare Technology Field

  • AMA Launches Center for Digital Health and AI Innovation

  • Merit Medical to Purchase Pentax Medical C2 CryoBalloon Technology

  • Nalu Medical PNS System Acquired by BSCI

  • Seelos Therapeutics, Inc. Assets, Acquired through Bankruptcy

  • Sunrise Labs Rebrands as Suntra MedTech Solutions™

  • Expanded approval for Navitor TAVR system – CE Mark in Europe

  • Philips launches smart telemetry platform for cardiac connectivity beyond the bedside

  • Globe® Pulsed Field System receives FDA approval


Upcoming Events & Webinars

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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
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?









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Upcoming Events & Webinars

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