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    Inspan interspinous plate fixation device granted FDA clearance for fusion and spinal stenosis from T1-S1

    Inspan LLC has announced that it has received US Food and Drug Administration (FDA) clearance for its interspinous plate fixation device to be used...

    EnSite X EP cardiac mapping platform gains US FDA approval

    Abbott has received clearance from the US Food and Drug Administration (FDA) for the EnSite X EP system with EnSite Omnipolar Technology (OT), a...

    Lazurite™ Announces FDA 510(k) Submission for its ArthroFree™ Wireless Camera System; is Recognized by AngelMD as One of the Best Startups of 2021

    Medical device and technology company Lazurite Holdings LLC announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA)...

    Glaukos Announces FDA 510(k) Clearance of iPRIME™

    Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal...

    Endotronix announces FDA approval for PROACTIVE-HF pivotal trial design change

    Endotronix has announced that the US Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal...

    Manus receives FDA Breakthrough Designation for NMP device

    Manus Neurodynamica, which develops and markets products and technologies for neuromotor assessment, has been granted Breakthrough Designation by the U.S. Food and Drug Administration (FDA) for...

    Implicity receives FDA clearance for AI-Powered ECG analyser

    Implicity has announced US Food and Drug Administration (FDA) clearance for a novel medical algorithm that analyses ECG data from implantable loop recorders (ILRs). “This...

    ClaroNav Kolahi Receives Chinese Regulatory Clearance for Navient Neuro-navigation System

    ClaroNav Kolahi Inc, a subsidiary of ClaroNav Inc, has received Chinese regulatory clearance from the National Medical Products Administration (NMPA) to market and sell its...

    Intuitive Secures FDA Clearance for 8 mm SureForm 30 Curved-Tip Stapler

    Intuitive (Nasdaq: ISRG) has today announced that the U.S. Food & Drug Administration (FDA) cleared the company’s fully wristed, 8 mm SureForm 30 Curved-Tip Stapler and reloads...

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