Information Sharing:
A Valuable Tool in Preventing Cyber Attacks

By MedTech Intelligence Staff

Information Sharing and Analysis Centers (ISACs), developed to help critical infrastructure industries prevent and become more resilient to cyber and physical security threats, are expanding their strategies to meet ever-evolving threats. Errol Weiss, Chief Security Officer of the Health-ISAC, discusses how these groups work to protect industry, emerging threats and how device developers and healthcare organizations are working together to protect patients.

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff

The Guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devise are returned to their established performance and safety specification.

HeartFlow AI Plaque Analysis Shows 95% Accuracy vs. Invasive Imaging

By MedTech Intelligence Staff

The multicenter international study, which enrolled 258 patients across 15 sites in the U.S. and Japan, compared HeartFlow’s automated deep-learning-based method for segmenting coronary atherosclerosis in coronary computed tomography angiography against the reference standard of intravascular ultrasound.

The Essential Guide to Strategic Supplier Management for Medical Devices

Medical Device Supply Chain Struggles? Download our FREE guide and discover how strategic supplier management builds resilience for a reliable flow of critical devices. We delve into the industry's unique challenges – strict regulations, quality needs, and constant innovation.

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A Framework for Navigating Information Polarization in
MedTech Investment

By Dr. Ashkan Eliasy

Information polarization affects public opinion. It can also affect investors. As we approach upcoming elections in different countries, it is crucial to understand how these political events could significantly reshape the landscape for MedTech investments. This article outlines an approach to help investors navigate understand the interplay of political climates, cultural norms, and healthcare policies without getting emotionally attached to them. It emphasizes the importance of open dialogue, diversity, critical thinking, and cross-cultural collaborations to determine the true potential of MedTech innovations.

Demystifying Regulatory Hurdles:
How to Navigate FDA Approval for AI-Enabled Medical Devices

By Jeanna Blitz, MD, and Cory Hayes, MPH,
Noridian Healthcare Solutions

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.

What is Regulatory Excellence in the
Medical Technology World?

By MedTech Intelligence Marketing Staff

Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.

Harnessing the Potential of Digital Quality:
Transforming Manufacturing Outcomes for Long-Term Success

By MedTech Intelligence Marketing Staff

Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.

Addressing engineering challenges in point-of-care diagnostic devices

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

The ultimate guide to the EU MDR and IVDR GSPR, 2nd Edition

Crossing the eSTAR Chasm – The First MedTech Benchmark Report on FDA’s 510(k) eSTAR Mandate

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

How redesign can help meet sustainability demands for medical devices

Please visit the newest MTI Resource Center
Post-Market Surveillance

The MTI Post-Market Surveillance Resource Center provides current news and information specific to maintaining medical device post market product quality & compliance. PMS is a critical component in achieving global Regulatory Excellence to ensure medical devices remain safe, effective, and reliable for end-users.

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