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Pre-approval Medical Devices

Goodwin

Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to...

Goodwin on

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more

Knobbe Martens

FDA Approves EnteroMedics’ Implantable Obesity Treatment Device

Knobbe Martens on

St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. ...more

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