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    Aiforia expands its portfolio of CE-IVD marked clinical pathology solutions with new AI model for breast cancer diagnostics

    Aiforia Technologies Plc, Press Release, Aiforia Technologies Plc announces the CE-IVD marking of the Aiforia® Clinical AI Model for Breast Cancer; ER. Adding to...

    Venus Medtech Obtains CE Certification for VenusP-Valve™

     A Chinese company named Venus Medtech announced that its self-developed VenusP-Valve™ Percutaneous prosthetic pulmonary valve replacement system was approved by the European Union (CE) for...

    Astura Medical bags FDA 510(k) clearance for El Capitan Oblique ALIF system

    Astura Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its El Capitan Oblique anterior...

    Alio Remote Monitoring Technology Receives First FDA 510(k) Clearance

     Alio Inc., announced it received FDA 510(k) clearance for its remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data...

    Fitbit’s PPG algorithm gains FDA clearance

    Fitbit has received clearance from the US Food and Drug Administration (FDA) for a new photoplethysmography (PPG) algorithm to identify atrial fibrillation (AF). The...

    TRUVIC Announces 510(k) Clearance for the Prodigy™ Thrombectomy System

    Truvic Medical, Inc., a wholly owned subsidiary of Imperative Care, Inc., announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)...

    FDA approves Abbott’s Aveir VR leadless pacemaker for slow heart rhythms

    Aveir VR leadless pacemaker can determine correct positioning prior to final implantation. The US Food and Drug Administration (FDA) has granted approval for Abbott’s Aveir single-chamber (VR)...

    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...

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