The Ninth Circuit rejected the view that off-label or contraindicated use of a medical device is per se material to payment. But different facts may lead to a different decision in a future case ...

The US Food and Drug Administration (FDA) has issued a warning about the off-label use of the Renuvion/J-Plasma device for dermal resurfacing and skin contraction procedures. The device is cleared ...

The FDA has labeled a recall of Inspire Medical Systems, Inc.’s (NYSE:INSP) nerve-stimulating implant for obstructive sleep apnea as Class I, the most serious kind. Inspire initiated a recall of ...