medical devices

Common FDA Regulatory Pathways for Uncommon Devices

To protect the hearing health of hearing aid users, researchers in the relevant areas have been studying the effects of EMI on hearing aids.

Alere, Inc. is voluntarily recalling their INRatio® and INRatio®2 PT/INR Monitoring System after working with the U.S. Food and Drug Administration (FDA).

The Food and Drug Administration (FDA) is now accepting comments and suggestions on a new draft guidance for medical device manufacturers working with additive manufacturing, commonly known as 3D printing.

This work presents a novel software tool intended to support compilation of coherent technical...

After nearly four years of work, the International Organization for Standardization (ISO) has published...

The U.S. Food and Drug Administration (FDA) is soon likely to require human factors...

As part of it overall effort to ensure the safety of patients, the U.S....

Australian researchers have created hybrid sound waves that could revolutionize vaccine administration and stem...

Designing technology for healthcare is tricky work, because although creativity plays an important role,...