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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

July 15, 2019

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Stakeholders vow to fight home health draft's behavioral adjustment

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Chinese government provides AI-aided software guidelines for health care market

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Industry supports most TGA proposals for CDx regs but seeks clarity

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said. Read More

Other news to note

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Appointments and advancements

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Regulatory front

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BioWorld MedTech stock report for public med-tech companies

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Financings

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Product clinical data for July 12, 2019

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Biointellisense gets boost from Fresenius as firms look to enhance patient monitoring

With an eye toward helping patients with chronic kidney disease (CKD) receive earlier interventions, Fresenius Medical Care North America (FMCNA) has made an investment in Biointellisense Inc., of Denver. Biointellisense is developing a medical grade data services platform for continuous health monitoring, predictive analytics and algorithmic clinical insights. Read More

Trial shows Neurolief's Relivion effective in treating migraine

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BioWorld MedTech's Neurology Extra

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