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The article offers information on the developments in digital medicine and digital therapeutics to date which may have been missed due to the Covid-19 pandemic. It discusses that all digital therapeutics, as per the Digital Therapeutics Alliance , share core principles such as publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals; and be reviewed and cleared or by regulatory bodies as required to support product claims of risk, efficacy, and intended use.

The article focuses on testing the performance of the new European Commission, which took over in November 2014 under the presidency of former Luxembourg prime minister Jean-Claude Juncker, in the approval of pharmaceuticals and medical devices. IT mentions responsibility of pharmaceutical regulations over Vytenis Andriukaitis, Lithuanian new Commissioner for directorate-general health and food safety. It discusses role of the EU in orphan medicines, advanced therapy medicinal products.

The article provides information on the integrated computerized system for data collection to enhance data security and data handling. It also states FDA latest guidelines for data handling. Topics discussed includes integrated electronic system, computerized systems and laboratory information management system (LIMS).

The article reports that unified plans are regulated in Europe to control medical devices and in-vitro diagnostic (IVD) tests. Topics discussed include low reliability of IVD tests due to inefficient evaluation of drugs and tests pairs by health technology assessment (HTA) bodies, the European Commission's two laws on IVD tests and medical devices, and the European Medicines Agency (EMA) to be consulted for suitability of devices and medicines.

The article focuses on approval of medical devices in the U.S. Topics discussed include market approval of devices approved by the U.S. Food and Drug Administration, views of Deborah Kotz, press officer at the FDA, on medical device safety to protect the public health and strengthening the reviews regarding approval of devices.

The article reports that the U.S. Food and Drug Administration (FDA) has approved the AcuFocus Kamra inlay implantable device to improve near vision presbyopia patients.

The article reports that the U.S. Food & Drug Administration (FDA) has approved the Share Direct Secondary Displays system from Dexcom Inc., through which diabetic patients will be able to share data with others from a continuous glucose monitor (CGM). Caregivers will be able to monitor their patients' glucose levels remotely with the system which comes with two mobile apps for Apple mobile devices.