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    Masimo Announces FDA Clearance of Pediatric Indication for SedLine® Brain Function Monitoring and the SedLine Pediatric EEG Sensor

    Masimo (NASDAQ: MASI) announced the FDA clearance of SedLine® brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor. With...

    Viz.ai Receives FDA 510(k) Clearance for Viz ANEURYSM

    Viz.ai, the world leader in artificial intelligence (AI) powered care coordination, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for...

    Gramercy Extremity Orthopedics Receives Clearance on Its Newest Plating Lines

    The RFID leader in medical devices expands its product offering by announcing FDA clearance for two new plating lines. Gramercy Extremity Orthopedics (GEO) announces FDA clearance...

    EvoEndo Announces US FDA 510(k) Clearance for Single-Use Unsedated Transnasal Endoscopy (TNE) System

    EvoEndo’s Single-Use Endoscopy System or the “EvoEndo System” eliminates the need for general anesthesia or conscious sedation during routine upper endoscopic proceduresThe EvoEndo System...

    Tandem Diabetes Care Announces FDA Clearance for the t:slim X2 Insulin Pump to Bolus Using the t:connect Mobile App

    Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, announced U.S. Food and Drug Administration (FDA) clearance of bolus insulin...

    Amnio Technology Launches Two New Dual-Layer Allografts, FDA Recognizes Products as Minimally Manipulated, Homologous Use HCT/Ps

    Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane...

    Ambu scores FDA clearance for single-use gastroscope and touchscreen display

    Though sustainability concerns usually make recyclable materials preferable to one-and-done options, when it comes to surgical devices, there’s an invaluable peace of mind and...

    Exactech Secures FDA 510(K) Clearance for Equinoxe® Planning App (v. 2.0)

    Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announces 510(k) clearance of the Equinoxe® Planning App (v. 2.0). The latest...

    Chemence Medical Receives FDA Clearance for new Exofin® Precision Pen

    Chemence Medical, Inc., a manufacturer and distributor of adhesive-based medical devices, announced it received Food and Drug Administration clearance to market and sell the...

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