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BIOTRONIK Receives FDA Approval For Next-Generation Family of Pacemakers

The Amvia Edge pacemaker platform introduces always-on, automatic MR detection algorithm to fully streamline MRI workflow. BIOTRONIK announced U.S. Food and Drug Administration (FDA) approval...

FDA converts approval process for new Alzheimer’s disease treatment to traditional approval

The US Food and Drug Administration (FDA) converted the approval process for Leqembi ( lecanemab-irmb), indicated for the treatment of adult patients with Alzheimer's...

Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

Amneal Pharmaceuticals, Inc. announced the launch of its authorized generic for Xyrem® (Sodium Oxybate) oral solution CIII in the United States. Sodium Oxybate oral solution,...

SimonMed Imaging Implements 3rd Generation iCAD Breast AI 3.0

SimonMed Imaging, one of the largest outpatient imaging providers in the US, announced it has completed the implementation of its third generation breast artificial...

ZEISS Accelerates Validation Process for Coordinate Measuring Machines to Achieve FDA Compliance

ZEISS is now offering customers validation solutions for their ZEISS Coordinate Measuring Machines (CMMs). The validation of quality assurance systems is essential for complying...
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