The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action. The notion that “everything old is new ...

As medical devices become increasingly connected and software-driven, cybersecurity cannot be treated as a final compliance checkpoint. It must be integrated throughout the entire product lifecycle, ...

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 ...

Medtronic reported robust fiscal 2026 results, fueled by strong growth in cardiovascular, medical surgical, and diabetes technologies, while advancing key product launches, regulatory milestones, and ...

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 – ...

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 ...

Boston Scientific Corporation announced it has invested $1.5 billion in return for an approximately 34% equity stake in MiRus LLC, a privately-held company developing and commercializing proprietary ...

PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities, according to the company Roche, will complement the company’s digital pathology portfolio to ...

Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in what we innovate and in how broadly those innovations can reach. For more ...