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    GLEAMER Receives FDA Clearance for Its Artificial Intelligence Software to Help Detect and Localize Fractures

    GLEAMER, a French MedTech company pioneering the use of artificial intelligence technology in the practice of radiology, announced that the United States Food and...

    SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance

    SurGenTec®, a privately held spine and orthopedic technology company based in Boca Raton, FL, announced that it has received clearance from the U.S. Food...

    Butterfly Network Introduces Butterfly Blueprint and World’s First FDA-Cleared AI Guidance & Interpretation Software to Support the Practical Application of Ultrasound Information

    System-Wide Ultrasound Platform, Blueprint, Works with Hospital and Health Systems’ Clinical and Administrative Infrastructures to Drive Point-of-Care Diagnostic Transformation Integration with Caption Health’s Platform Brings...

    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...

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