Food and Drug Administration

FDA Warns Public and Health Care Professionals Not to Use Needle-free Devices for Injection of Dermal Fillers

WASHINGTON, D.C. — The following quote is attributed to Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in FDA’s Center for Devices and Radiological Health:

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LifeScan

Study: LifeScan’s OneTouch Blood Glucose Meter Improves Diabetes Management in Underserved Hispanic Population

MALVERN, PA — LifeScan announced recent findings from its Tu Salud (Your Health) clinical trial showing that using its OneTouch Verio Flex® meter with a Spanish-language version of its OneTouch Reveal® mobile application (app) led …

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Centinel Spine Continues To Innovate in Total Disc Replacement Through First Case in U.S. With Angled Implants

New Study Demonstrates Long-term Effectiveness of Centinel Spine’s prodisc L Total Disc Replacement

WEST CHESTER, PA — Centinel Spine®, LLC, a global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, recently announced findings of a new study first presented …

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FDA

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process

WASHINGTON, D.C. — The U.S. Food and Drug Administration recently granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification …

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