Given the lack of information on their effectiveness and the unreasonable risks for illness or injury, spinal sphere devices should be regulated as Class 3 devices that require premarket approval (PMA ...

The Google Home app is getting an update with a home panel that allows users to better monitor home devices. This comes after Google announced the public rollout of the revamped version of its app.

A health advisory committee recommended that Medicare consider measures such as time in range and safety data when making coverage decisions about diabetes devices. In a Tuesday meeting, the Medicare ...

A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The ...

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Please provide your email address to receive an email when new articles are posted on . An FDA panel voted that the benefits of a transcatheter edge-to-edge repair device outweigh risks in severe ...

Please provide your email address to receive an email when new articles are posted on . An FDA panel voted that for adults with uncontrolled hypertension, the benefits of a radiofrequency renal ...

Medtronic suffered a regulatory and competitive setback Wednesday after a U.S. Food and Drug Administration advisory panel expressed concerns about Symplicity Spyral, a device to treat hypertension.

While the FDA is proposing to reclassify two class III computer-aided melanoma detection devices as class II devices, most members of its General and Plastic Surgery Devices Panel suggested that such ...

The FDA's Circulatory Systems Devices Panel of the Medical Devices Advisory Committee backed Recor Medical Inc and its parent company, Otsuka Medical Devices Co Ltd's (OTC:OTSKF) (OTC:OTSKY) ...

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 ...