According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap ...

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 ...

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 ...

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 ...

Boston Scientific will invest $138 million to build a 500,000-square-foot global medical device distribution facility in Plainfield, Indiana, creating up to 300 high-wage jobs and expanding the ...

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 – ...

Boston Children’s Hospital physicians say one of the greatest risks in pediatric ICUs is delayed de-escalation of care, which can expose children to prolonged ventilation, sedation, and vasoactive ...

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 ...

Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, ...