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The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs' electrosurgical device SIRA RFA.

Paige.AI has received breakthrough device designation from the US Food and Drug Administration (FDA) for a cancer diagnosis solution based on artificial intelligence (AI).

The US Food and Drug Administration (FDA) has expanded the indication of Abbott's MitraClip device to include the treatment of heart failure patients with clinically significant secondary or functional mitral regurgitation (MR).

3D printing solutions provider Materialise has obtained clearance for its Mimics Enlight cardiovascular planning software suite from the US Food and Drug Administration (FDA).

The US Food and Drug Administration (FDA) has approved the new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity.

The US Food and Drug Administration (FDA) has issued a statement warning healthcare providers about potential complications in patients fitted with both programmable cerebrospinal fluid (CSF) shunt systems and certain magnetic hearing devices.

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.