As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical ...

Key Shortcomings: Inflexible Planning Delays caused by late-stage clinical requirements or regulatory changes can derail go-to-market strategies. For example, a 2021 FDA case study highlighted ...

The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center. That would ...

MTI Viewpoints are insights shared by industry relative to healthcare and the advancement of medical technology.

Cardiovascular conditions are the leading cause of death. Fortunately, industry leaders are discovering innovative ways to diagnose and treat them. See how mobile apps and AI will change this field in ...

Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a potential ban across the European Union. Such a ban would introduce a need ...

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 ...

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 ...

FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, ...

For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a ...