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FDA Puts Strengthened Emergency Authority To Use For Diagnostics

The agency’s diagnostic office is putting to the test new authority to grant emergency use authorization for a product before an emergency is officially declared, with an upcoming coronavirus test and a recently authorized flu test.

FDA diagnostic officials say they are making good use of a recently enacted law that allows the agency to grant emergency use authorization to products for public health issues even before they are officially designated emergencies.

The agency has had authority for years to temporarily approve drugs, diagnostics and other tools with less evidence than the normal standard in response to a public health emergency. But...

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Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
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• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
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Medtronic Eyes Up to $350M Tariff Hit in FY26, Leans On Cost Controls And Pricing Strategy

 
• By Shubham Singh

Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.