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9/18/2018

European regulators have granted Philips CE mark approval for its beltless Avalon fetal and maternal monitoring device. The electrode technology-based device, which comes with a single patch and reusable pod, updates a patient's EMR with uterine activity, fetal and maternal heart rate and other patient data using the company's obstetrical information management system.

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FDAnews
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Philips, Philips, EU
9/18/2018

Researchers analyzed 12 years' worth of data for 23,422 trauma patients at an urban Level I trauma center and found that gunshot victims were five times more likely to need a transfusion, needed 10 times more units of blood and were 14 times more likely to die compared with other trauma patients. The differences are due to the dramatic severity of firearm injuries compared with other trauma, the study team said in the journal Transfusion.

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HealthLeaders Media
9/18/2018

National University of Singapore scientists are developing a portable test for a range of diseases including hepatitis, dengue, Ebola, malaria and Zika. The assay is also intended to detect human papillomavirus, cancer and genetic conditions.

9/18/2018

Amyotrophic lateral sclerosis does not appear to affect visual-spatial skills but does appear to affect behavior and thinking skills, and cognitive and behavioral deficits may be progressive, according to a study published in Neurology.

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Reuters
9/18/2018

The US Preventive Services Task Force says there is not enough evidence to support adding C-reactive protein levels measured by high-sensitivity assays, coronary artery calcium score, or ankle-brachial index to traditional cardiovascular disease risk assessments in asymptomatic adults. USPSTF recommended more research on how adding hs-CRP, ABI, CAC and CVD outcomes affects clinical decision thresholds and patient outcomes, particularly in diverse populations.

9/18/2018

Hepatic circulating epithelial cells have potential as a biomarker for diagnosing and monitoring chronic liver disease and hepatocellular cancer. In a recent study, circulating epithelial cells of hepatocyte origin in the blood were detected using a novel liquid biopsy cell-sorting device.

9/17/2018

The USDA and the FDA will partner to hear public discussion about the possible hazards related to lab-grown meat products and techniques to control such hazards. Also included in the discussion will be labeling and naming issues, such as using the terms "clean meat," "lab-grown," "cell-based" or "plant-based" for lab-grown products.

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Food Safety News
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FDA, USDA
9/17/2018

FDA Commissioner Scott Gottlieb called for new funding mechanisms to support the battle against antimicrobial resistance, while also disclosing the agency's 2019 strategic plan that focuses on AMR. Gottlieb spoke of four crucial areas to address, including the development of products and surveillance tools for antimicrobial use and resistance, promotion of antimicrobial stewardship and support for research initiatives to discover alternative treatment approaches.

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BioCentury
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Commissioner Scott Gottlieb, FDA
9/17/2018

The NIH has launched the Cure Sickle Cell Initiative, a program that will create a national repository for data on the disease and focus on developing gene therapies for patients with sickle cell disease, with Dana-Farber Cancer Institute's Dr. Edward Benz Jr. as its executive director. Patient engagement will be key to the initiative, with patients working together with researchers in search of effective therapies for SCD and in the development and recruitment of participants for clinical trials.

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Rare Disease Report
9/17/2018

An FDA fast-track designation was granted to ArQule's miransertib, being developed as a treatment for patients with PIK3CA-related overgrowth spectrum. ArQule has an ongoing Phase I/II trial for the indication.

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eMPR
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FDA, ArQule