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 ...

As healthcare pushes forward in digital transformation, AI has emerged as a critical tool in optimizing electronic medical records. EMRs remain both vital and frustrating. Clinicians wrestle with ...

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 ...

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

Holmes appears to be headed for prison after an appeals court rejected her bid to remain free while she tries to overturn her conviction in a blood-testing hoax that brought her fleeting fame and ...

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 ...

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 ...

In the medical device industry, engineering quality is paramount. This is a high-stakes field, and the FDA has zero tolerance for violations. A robust development process not only enhances quality, ...

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 ...