Reverse engineering carries a reputation problem in medical device circles; it sounds like copying. In practice, it's a legitimate engineering discipline with specific, defensible use cases: replacing ...

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, ...

Medical device software development teams have always struggled with a deceptively simple question: How much of the system is actually complete? Project dashboards, requirements databases, sprint ...

Zimmer Biomet will hire 500 professionals over the next three years for its new Bengaluru technology centre, expanding its AI, software engineering, and R&D capabilities as India strengthens its ...

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports.

Artificial intelligence is already inside regulatory affairs functions across the medtech industry. Teams are using it to summarize guidance documents, support first-pass drafting, compare labeling ...

CMS’s proposed expansion of Medicare TAVR coverage to include select asymptomatic severe aortic stenosis patients and reduce access barriers for symptomatic patients could significantly increase TAVR ...

The most recent AI thought leadership published on MedTechIntelligence.com. We are seeing it everywhere, Artificial Intelligence in our daily activities – smart thermostats and smart lights in our ...

Consider a hypothetical scenario that reflects a pattern increasingly reported by manufacturers: a 510(k) submission for an AI-powered diagnostic tool with 99% sensitivity. Strong numbers. Solid ...

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 – ...

Tecomet and Orchid Orthopedic Solutions have completed a merger to create a larger global contract manufacturing platform serving MedTech and Aerospace & Defense customers with expanded capabilities ...

Up to 1,000 jobs globally could be cut over the next three years as part of a major restructuring effort following weaker first-half earnings driven by declining sales, currency pressures, and weak ...