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.

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

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: ...

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 ...

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 ...

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, ...

Overcoming 21 CFR compliance challenges - stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare ...

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 ...