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Boston Scientific has received the US Food and Drug Administration (FDA) approval for the use of LOTUS Edge Aortic Valve System to treat severe aortic stenosis.

The US Food and Drug Administration (FDA) has granted approval to Medtronic's Attain Stability Quad MRI SureScan left heart lead. The device is the only active-fixation left heart lead, and is designed for precise lead placement and stability.

Israeli company Zebra Medical Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an artificial intelligence (AI)-powered chest X-ray triage product.

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.

Qiagen has launched the new therascreen PIK3CA RGQ PCR Kit as a companion diagnostic for the detection of patients who could benefit from treatment with Swiss pharmaceutical company Novartis' new breast cancer drug, Piqray (alpelisib).