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 ...

Harnessing the power of big data from medical device software offers real-time monitoring, predictive analytics, and personalized treatment plans, significantly enhancing the doctor to patient ...

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.

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 ...

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for ...