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8/17/2018

Viveve has started a trial of its cryogen-cooled monopolar radiofrequency technology intended for treatment of stress urinary incontinence in women. The study, which will include up to 10 sites across Canada, will randomize 100 patients using a 2-to-1 ratio for experimental or sham treatment.

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MassDevice (Boston)
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urinary incontinence, Viveve
8/17/2018

The FDA has given CoreLink Surgical 510(k) clearance for its Foundation 3D anterior lumbar interbody fusion device, which features the company's Mimetic Metal technology and patent-pending StrutSure technology.

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Compelo
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FDA, CoreLink
8/17/2018

Scripps Research Institute scientists found that the enzyme YRSACT, which is known to play a role in decoding DNA, appears to increase platelet production in tests of animals, according to a study in the journal Proceedings of the National Academy of Sciences. Researchers say YRSACT works by boosting production of platelet-producing megakaryocytes, and the findings suggest a new drug target to treat thrombocytopenia.

8/17/2018

Health officials in California reported in the journal Emerging Infectious Diseases that the state had 588 cases of travel-related Zika virus infection from November 2015 to September 2017, and 64% of the probable viremia cases involved people living in counties where Aedes mosquitoes have been found. Meanwhile, the National Institute of Allergy and Infectious Diseases has begun a trial of an experimental live attenuated Zika vaccine in 28 healthy volunteers.

8/17/2018

A late-stage study in The New England Journal of Medicine found 83% of 40 adults with multidrug-resistant HIV-1 infection who were treated with ibalizumab, or Trogarzo, experienced reductions in viral load.

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HealthDay News
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ibalizumab
8/16/2018

Thirty-one of 45 children's breakfast foods and cereals, such as granolas, oats and snack bars, had levels of glyphosate, a weed-killing chemical associated with cancer, exceeding what some consider to be safe levels for children, an Environmental Working Group report found. The report also showed that only two products didn't contain glyphosate.

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CBS News
8/16/2018

Preliminary CDC data showed US drug overdose mortality hit record levels last year, increasing to more than 72,000 deaths, driven mainly by the continued increase in fatalities involving fentanyl and other synthetic opioids. Overdose deaths from synthetic opioids rose by more than 9,000 from the prior year, reaching almost 30,000 deaths in 2017, while fatalities from heroin, prescription opioids and methadone have dropped.

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drug overdose, CDC, fentanyl, heroin, methadone
8/16/2018

Two EHR-integrated, web-based tools that use Substitutable Medical Applications and Reusable Technologies on the Fast Healthcare Interoperability Resources standard are being launched by Geisinger Health System and Merck. The Family Caregiver app is designed to support communication between health care providers and caregivers, while the MedTrue app is meant to improve medication adherence and reconciliation by integrating medication data with clinical workflows.

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EHR Intelligence
8/16/2018

Vertex Pharmaceuticals' Kalydeco, or ivacaftor, was approved by the FDA for pediatric patients age 12 months to younger than 2 years old with cystic fibrosis who have at least one mutation in the cystic fibrosis transmembrane conductance regulator gene that is responsive to the drug based on clinical and/or in vitro test data. The decision was backed by data from a late-stage trial, in which the drug showed a consistent safety profile to that seen in prior late-stage studies of older children and adults with CF.

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Vertex Pharmaceuticals, Kalydeco, FDA
8/16/2018

Onspira Therapeutics' OSP-101, being developed as a treatment for post-lung transplant patients with bronchiolitis obliterans, received orphan drug designation from the FDA.

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eMPR