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    Researchers Pilot Ingestible Electronic Sensor to Monitor Microbiome

    Australian researchers have conducted a human trial that they say illustrated the potential role for electronic-based gas-sensing capsules in understanding aspects of the intestine and its microbiota in health, according to an article published online on Monday in Nature Electronics . The ingestible sensors used in the trial can sense oxygen, hydrogen and carbon dioxide by using a combination of thermal conductivity and semiconducting sensors, the researchers said,...
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    European Regulatory Roundup: EMA Looks to Cut PML Risk in Patients Taking MS Drug Tysabri (18 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Aims to cut Risk of PML in Patients Taking Biogen’s Tysabri with Frequent MRI Scans The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Tysabri, the Biogen multiple sclerosis drug associated with increased risk of developing progressive multifocal leukoencephalopathy (PML). To mitigate this danger, PRAC is recom...
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    FDA Accepts for Review First NDA for a 'Digital' Medicine

    The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet. The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs. In the case of this new drug application, the sensor is paired with Otsuka...
  • FDA Clears Ingestible Medical Device Aimed at Boosting Adherence

    The US Food and Drug Administration (FDA) has cleared an ingestible medical device manufactured by Proteus Digital Health through its de novo clearance pathway, clearing the way for the futuristic device to get to market. The de novo process is used for low-risk novel devices that would otherwise be required to submit a premarket approval (PMA) application and be subjected to expensive clinical trials. Proteus' device, the Ingestion Event Marker (IEM), was described...