Introduction: A Wake-Up Call from Recent History In the world of MedTech, traditional development processes often slow down innovation. Medical device manufacturers face an environment where global ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR ...

Attrayee (Atty) Chakraborty, MS, MSc. is a Quality Systems Engineer at Analog Devices (ADI), a global F500 semiconductor company. She works in the Digital Healthcare division at ADI and is critically ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges.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 ...

Remote healthcare has quickly evolved from an idea in the minds of providers to the new standard defining modern healthcare. Patient monitoring has experienced a journey that is redefining flexibility ...

The value-based care model, with a substantial monetary budget, necessitates on-time and correct risk stratification. As a result, new and incumbent care providers and payers are reinventing ...

EU Clinical Trials Transition The conduct of clinical trials in the European Union (EU) and European Economic Area (EEA) has been regulated by the Clinical Trials Directive (CTD) since 2004. The CTD ...

Jenny Levinson is Vice President, Global Health Economics & Market Access, at Boston Scientific, a global medical technology leader. For the past 30+ years, she has held roles in public policy, health ...

The healthcare industry is a complex web of clinical, administrative, regulatory, and financial processes. Despite the advancements in health information technology and artificial intelligence, ...

As of October 2023, the FDA had identified 692 artificial intelligence/machine learning- enabled products that received clearance for marketing, with sustained growth projected for both submission ...

The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must ...