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Sequana Medical N : Statutory auditor's report on the consolidated accounts for the year ended 31 December 2023

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STATUTORY AUDITOR S REPORT TO THE GENERAL SHAREHOLDERS MEETING SEQUANA MEDICAL NV ON THE CONSOLIDATED ACCOUNTS FOR THE YEAR ENDED

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Your Digital Health Regulation Questions Answered - Healthcare

The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). ....

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Your Digital Health Regulation Questions Answered | Fenwick & West LLP

Regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).. ....

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Kardium Announces Completion of Paroxysmal Enrollment in the PULSAR IDE Study

VANCOUVER, British Columbia, April 02, 2024 Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF) using pulsed field ablation (PFA), announced today the successful completion of enrollment in the paroxysmal cohort of the pivotal PULSAR IDE (Investigational Device Exemption) study. This achievement marks a significant milestone in the journey to bring this groundbreaking technology to patients in the United States, with ....

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Integrum AB: A new record revenue quarter with 61% growth

/PRNewswire/ THIRD QUARTER 2023/24 (NOV - JAN) Net sales amounts to 30.1 (18.7) MSEK, which is an increase of 61% compared with the corresponding period. ....

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