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 ...

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 ...

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 ...

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 ...

Widgets aren't useless, Microsoft just buried the good parts.

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.

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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 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 ...

(RTTNews) - Abbott (ABT) said that the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration confirmed 13 to 1, with 0 abstention that ...

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 ...