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Establishment Labs Announces FDA Clearance of Motiva Flora SmoothSilk Tissue Expander

NEW YORK, October 16, 2023 Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Motiva Flora® SmoothSilk® Tissue Expander. ....

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Medtronic Receives FDA Approval for Expanded MRI Labeling of InterStim™ SureScan™ MRI Leads

Medtronic Receives FDA Approval for Expanded MRI Labeling of InterStim™ SureScan™ MRI Leads
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DUBLIN, Feb. 18, 2021 /PRNewswire/ Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for expanded MRI labeling of its InterStim™ II and InterStim™ Micro sacral neuromodulation (SNM) systems that use SureScan™ MRI leads. The updated MRI Guidelines allow for a wider range of MRI scan parameters and shorter wait time between MRI scans, thereby improving patient access to MRI exams and adding flexibility for MRI providers. It applies to existing and future implants of InterStim systems that use SureScan MRI leads. ....

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