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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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.

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 FDA’s Gastroenterology-Urology Devices Panel voted unanimously that LINX’s Reflux Management System, a laparoscopically implanted device designed to treat gastroesophageal reflux disease, has a ...

Johnson & Johnson’s billion-dollar bet on a novel implant for heart failure hit a roadblock this week, with an FDA advisory panel unanimously voting against its risk-benefit profile. The V-Wave ...

The longstanding problem of pulse oximeters providing less-accurate readings for people with dark skin tones got another look Friday from a panel of experts for the US Food and Drug Administration.

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 an ultrasound renal ...