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 ...

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 ...

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(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 ...

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 ...

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 ...

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 ...