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 ...

Industry groups hoping to lessen impacts of Donald Trump’s “Liberation Day” plans on medical products and MedTech development sent letter to the U.S. Trade Representative. Since Donald Trump’s ...

Black Book’s ad hoc survey of 200 healthcare executives reveals real-time disruptions, cost inflation, and stalled innovation as Trump-era tariffs expand across key healthcare imports. Press Release: ...

MTI Viewpoint: I expect fundamental changes to our medical device ecosystem; not all companies will survive them. The ability to consistently use AI will also determine who will be among the survivors ...

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.

Could MedTech find itself as the collateral damage if an RFK Jr. run HHS "goes wild" with FDA regulation of pharma and processed foods?

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 ...