Planes, trains, and device regulation – the fatigue of regulatory challenges: MTI REGULATORY REPORT 2024 (part 1)

By Rich West

MTI Regulatory Report 2024 data overwhelmingly suggests regulatory resources throughout the industry are being stretched. Time/Bandwidth is the top medical device regulatory challenge faced during 2024, potentially leading to industry-wide regulatory fatigue and driven by changing global compliance regulations in recent years.

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GenAI
GenAI

Personalized Care with GenAI-powered risk stratification benefits the care delivery model

By Yunguo Yu

The value-based care model, with a substantial monetary budget, necessitates on-time and correct risk stratification. As a result, new and incumbent care providers and payers are reinventing healthcare delivery, looking towards cutting-edge GenAI and machine learning technology to radically transform the healthcare delivery paradigm. This article explores how GenAI and machine learning-based risk stratification are revolutionizing a new era of personalized care, resulting in improved healthcare functions for payers and providers.

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3D surgical navigation
3D surgical navigation

Spinal Deformity Surgery with AI-Powered Surgical Guidance and Advanced Visualization Techniques

By Tommy Carls

Light field technology is illuminating a path to a deeper understanding of patient anatomy, surgeon methodology, and surgical environments. Traditionally, spine surgery navigation has depended on surgeons combining pre-operative imaging with intra-operative anatomy to execute their treatment plans. However, with light field technology and depth sensors, these technologies digitize the entire operative field, merging it seamlessly with preoperative imaging, effectively bridging the gap between unseen and visible physical anatomy of the spine. This provides surgeons with a three-dimensional anatomical view that exceeds what the naked eye can discern.

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Nicole Coustier
Nicole Coustier

Reimbursement Déjà Vu: Lessons for AI/ML Medtech Founders from the Molecular Diagnostics Industry

By Nicole Coustier

Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology’s function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.

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