Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in ...
The agency launched Elsa 4.0, an upgrade to the agency’s internal AI tool available to all FDA staff, from scientific ...
PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities, according to the ...
In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.” ...
FDA Commissioner Marty Makary says, one-day inspections can strengthen our inspectional approach by focusing our time and ...
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, ...
The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J's expanding cardiac ablation ...
Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally ...
SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach ...
The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.
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