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April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products,” in which the FDA lists...
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In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT,...
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Towards the end of 2019, the German Federal Parliament introduced a simplified process for approval and reimbursement of digital health apps...
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In DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics we identified several potential payment models for monetizing the value of...
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From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA (Agenzia Italiana del Farmaco) evaluated a total of 166 Dossiers – 28...
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According to the Digital Therapeutics Alliance (DTA), digital therapeutics (DTx) are products that deliver “software-generated therapeutic...
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In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill...
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As a critical element of accelerating the healthcare payment reform, the pilot of Diagnosis Related Groups (DRGs) in 30 major cities across China was...
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Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in...
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Italian public healthcare structures can buy medical devices only via tenders. Up to 2016, competitive pricing was the main rule for tender winners....
