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jacob logan

Boston Scientific gets FDA approval for LOTUS Edge system - 0 views

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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.
jacob logan

Medtronic's Attain Stability left heart lead receives FDA approval - 0 views

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    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.
jacob logan

Zebra Medical receives FDA clearance for AI chest X-ray product - 0 views

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    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.
jacob logan

Formal FDA enforcement action declines under Trump - 1 views

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    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.
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