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MedApp S.A., the developer of the CarnaLife Holo system, participated in the first edition of MCSC, which was evaluated by a multidisciplinary scientific Institutional Review Board of the Institute of Mother and Child. On May 1, 2023, MedApp S.A. received a positive decision from the United States Food and Drug Administration (FDA) regarding the registration of the CarnaLife Holo system as a Class II medical device (510(k) Number: K221870). This approval permits the distribution and clinical use of CarnaLife Holo on the U.S. market, confirming its compliance with regulatory requirements for medical technologies.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"262"}}