The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific ...

FDA Commissioner Marty Makary says, one-day inspections can strengthen our inspectional approach by focusing our time and ...

PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities, according to the ...

Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in ...

In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.” ...

Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, ...

The medical device industry is navigating a perfect storm of rising material expenses, strict regulatory demands, and pressure to innovate faster. With costs climbing across the value chain, ...

SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach ...

Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally ...

Edwards announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained ...

No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of ...