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 ...

With the acquisition of Amplitude Vascular Systems announced recently, Stryker joins the IVL technology race with Johnson & Johnson and Boston Scientific. Industry analysts noted cardiovascular ...

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 ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S.

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges. Artificial Intelligence (AI) and Machine Learning ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

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 – ...

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 ...

New technology designed to provide a single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures. Boston ...

Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare ...

Strategic Evaluation Criteria (Weighted) Once the threshold criteria are satisfied, the following factors can be analyzed and weighed according to the specific context of the technology and the ...

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