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The US Food and Drug Administration (FDA) has rejected Helius Medical Technologies' premarket submission for the Portable Neuromodulation Stimulator (PoNS) device due to a lack of data.

Biotronik has secured approval from the US Food and Drug Administration (FDA) for the use of its Acticor and Rivacor cardiac rhythm management (CRM) devices to treat heart arrhythmias.

Compliance and enforcement actions by the US Food and Drug Administration (FDA) have dramatically declined under the Trump administration, with medical devices seeing the steepest drop, according to a new report.

The US Food and Drug Administration (FDA) has labelled a recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, or high risk.

Material sciences company W. L. Gore & Associates has received approval from the US Food and Drug Administration (FDA) for its Tag Conformable Thoracic Stent Graft, a thoracic endovascular aortic repair (TEVAR) device.