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As a result of the new European Union Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark under the previous Medical Devices Directive (MDD), will need to be re-certified. In April 2020, the...
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We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health...
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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...
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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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The Boston-based Institute for Clinical and Economic Review (ICER), an independent research organization that conducts health technology assessments...
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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...
