The market opportunities lie in providing comprehensive training for computer system validation aligning with FDA regulations, offering hands-on practice, agile and waterfall methodologies comparison, ...

In connected device development and validation, our focus shifts to the solution and how to bring it to life, starting with creation and system architecture. This is the third installment in my series ...

In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense ...

As the fervor around ending animal testing in drug development has grown since President Donald Trump started his second term, a group of nonprofits, corporations and regulators has been meeting to ...

Mānoa, HI—Research from the University of Hawaiʻi at Mānoa’s College of Engineering could lead to stronger, longer-lasting soft medical devices, wearable tech, and robotics. Assistant Professor Te ...

This pilot study evaluates a newly developed point-of-care (PoC) device designed to measure bilirubin levels in human blood serum using a microfluidic cartridge and optoelectronic sensing module.

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

They’ve got some nerve! Vagus nerve stimulators are making waves as a potential way to relax, sleep better and improve gut health. But an expert on the vagus nerve warns that noninvasive VNS devices ...

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