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FDA

Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.

CereVasc’s eShunt® System Gains FDA Breakthrough Designation

“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Dan Levangie, Chairman & CEO of CereVasc, Inc. “We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.”

Nanox Receives FDA Clearance for General Use of New Imaging System, Nanox.ARC X

First FDA clearance for Nanox.ARC X to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal and paranasal indications. The enhanced imaging system features sleek design with smaller footprint; simplified ‘plug and play’ installation process and the system design enables software upgrades and new capabilities to be added remotely following future regulatory clearances