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 ...

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional ...

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 ...

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 ...

Medtronic announced several regulatory milestones for its Hugo robotic-assisted surgery platform, including FDA submissions for general and gynecologic surgery indications and the LigaSure™ RAS ...

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 – ...

Artivion has finalized its acquisition of Endospan Ltd., adding the FDA-approved NEXUS Aortic Arch System to its portfolio of aortic arch therapies. The deal strengthens the company’s position in the ...