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 ...

A 15-person FDA Circulatory System Devices Panel has unanimously voted against Johnson & Johnson MedTech’s V-Wave Ventura interatrial shunt, creating a setback for the major medtech leader. The panel ...

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.

GAITHERSBURG, MD — Instrumentation used to place surgical mesh during urogynecological procedures should be subject to stricter manufacturing requirements and more detailed labeling, according to US ...

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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.

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 ...

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