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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.
Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test
FDA

Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test

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FDA

Ortho-R Receives FDA Regulatory Designation and Jurisdictional Assignment

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FDA

FDA Takes Action to Limit Inorganic Arsenic Levels in Infant Rice Cereal

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FDA

FDA EUA Issued for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients

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FDA

Siemens Healthineers Obtains First FDA EUA for Semi-Quantitative Antibody Test

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FDA

InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads Receive FDA Approval

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FDA

FDA Grants An EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms

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FDA

FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

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FDA

Zebra Medical Vision Secures its First FDA Clearance in Oncology, Boosting Early Detection of Breast Cancer in Mammograms

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FDA

Vesta™ RF Cannula Receives FDA Clearance

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