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    Regulatory Approvals

    GE Healthcare Receives FDA Approval of First-Ever Software to Help Automate Anesthesia Delivery and Reduce Greenhouse Gas Emissions During Surgery

    End-tidal Control software helps reduce greenhouse gas emissions and costs by cutting anesthetic agent wasteEnables anesthesia providers to set precise targets for oxygen and...

    Aidoc’s AI-powered X-ray system cleared to detect collapsed lungs

    Aidoc said it has received FDA 510(k) clearance for AI-powered X-ray detection of pneumothorax, also known as a collapsed lung. It’s the latest indication for...

    PocDoc secures CE mark for AI reader of lateral flow tests

    PocDoc has secured a CE mark for its AI driven digital reader of lateral flow tests. The cloud-based system allows any smartphone or tablet...

    Microbot Medical Files FDA Pre-Submission Package for LIBERTY® Robotic System

    Microbot Medical Inc. has announced that it has filed its pre-submission package for the LIBERTY® Robotic System with the U.S. Food and Drug Administration (FDA), addressing the regulatory...

    Envista Obtains FDA Clearance for Assisted Intelligence Mandibular Nerve Tracing

    Envista Holdings Corporation (NYSE: NVST) ("Envista") -- Envista announced the 510(k) Food and Drug Administration (FDA) clearance of its Assisted Intelligence (AI) mandibular nerve tracing...

    Biobeat widens lead over Apple, Fitbit with FDA nod to add more vital sign monitoring to smartwatch

    Though major tech developers like Apple and Google-owned Fitbit have taken center stage in the race to infuse wearable technology with as many health-tracking...

    Lazurite’s ArthroFree™ Wireless Camera System for Minimally Invasive Surgery Receives FDA Market Clearance

    Lazurite announced that its ArthroFree™ System is now the first and only wireless camera system for minimally invasive surgery to receive U.S. Food and...

    Wision A.I. secures FDA nod for polyp-spotting colonoscopy tech

    Used during a standard colonoscopy, the newly FDA-cleared EndoScreener software relies on deep learning artificial intelligence to identify potentially precancerous polyps that have formed...

    FDA clears Orthofix TrueLok Evo Ring fixation system

    Orthofix announced that it received FDA 510(k) clearance for its TrueLok Evo Ring Fixation system. The Lewisville, Texas-based orthopedics company designed the device for complex...
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