International experts validate Singapore device regulation system. Singapore's Health Sciences Authority (HSA) reached ...

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...

Connected medical devices can improve patient care and operational efficiency. However, they also introduce new privacy and security risks. Healthcare providers should rethink their privacy and ...

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all ...

LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

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Stratasys believes the CE marking will enable broader clinical use and expand patient access to 3D printed dentures, crowns, ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

Add Yahoo as a preferred source to see more of our stories on Google. The FDA defines LifeVac as a suction device to resolve complete airway obstruction after failed BLS choking protocols. Credit: ...