Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

Etienne Nichols, a medical device guru and community manager at Greenlight Guru, recently posed an interesting question to his LinkedIn network: If you were in charge, what regulation would you change ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

As new consumer hardware and software capabilities have bumped up against medicine over the last few years, consumers and manufacturers alike have struggled with identifying the line between “wellness ...

A Senate committee is set to advance sweeping legislation regulating medical-device approvals within days of the panel’s receiving the government-industry joint proposal that forms the basis of the ...

Millions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that pushes air into their lungs, supporting their breathing during sleep. These airway pressure ...

One of the main challenges for medical device developers is ensuring clinical trials meet the expectations of all regulatory authorities in the regions where they wish to release. This will be a ...

On April 11, AEI’s Brian J. Miller hosted Jesse Ehrenfeld of the American Medical Association and Jeff Shuren of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health to ...