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    Regulatory Approvals

    FDA aiming to modernize 510(k) process that many radiology devices must go through

    The U.S. Food and Drug Administration announced Sep 6 that it is hoping to modernize the premarket notification 510(k) program that many radiology devices...

    Boston Scientific Announces FDA Approval for the Latest-Generation WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device

    Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration approval for the latest-generation WATCHMAN FLX™ Pro Left Atrial Appendage...

    FDA authorise Xenex LightStrike+ UV Robot

    Xenex’s microbial reduction LightStrike+ UV Robot is granted FDA authorisation marking a new classification type for UV medical devices. Ultraviolet (UV) disinfecting solution provider, Xenex...

    Cortical receives 510(k) clearance from FDA for BARM system version 1

    BPH Energy’s investee company Cortical Dynamics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Brain Anaesthesia Response Monitor (BARM) system...

    Stethophone™ Receives Full Approval for Use by Patients and Their Families in Ukraine

    Ukraine clears breakthrough SaaMD that enables people to usetheir smartphones as clinical-grade devices that listen for cardiovascular disease at home. Sparrow BioAcoustics  announced it has...

    ICU Medical Receives FDA Clearance for Plum Duo™ Infusion Pump and LifeShield™ Infusion Safety Software

    The clinician-driven design of the precision system is the foundation of ICU Medical's long-term IV systems product road map that seeks to blend ease...

    FDA clears AI algorithms to gauge success of complex arrhythmia ablation

    The FDA cleared two AI algorithms to evaluate the success of PVI ablation for complex arrhythmias. These tools are available on a price-per-use basis. CathVision announced...

    Medtronic’s spinal cord stimulator receives CE Mark

    Inceptiv is claimed to be the only SCS system in Europe that provides both full-body 1.5T and 3T MRI access. Medtronic has secured CE Mark approval for its...

    Levita® Magnetics Wins FDA Clearance for Pioneering MARS™ System

    Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration...
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