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10/22/2018

Olympus has announced the US release of the Endoeye Flex 3D and FlexDex needle driver laparoscopic surgical tools. The company is integrating its Endoeye Flex 3D technology with the wristed needle driver to help simplify suturing in areas that are hard to reach during minimal access surgery procedures.

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MassDevice (Boston)
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Olympus
10/22/2018

A study of more than 1,000 HIV-positive former inmates in the journal PLOS Medicine found that less than 50% continued to receive treatment three years after release. The rate of continuous care declined to 42.5% after three years, and people who were later sent back to prison had higher rates of care.

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MD Magazine online
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HIV-positive
10/22/2018

An attack by rebels in the Democratic Republic of Congo is slowing efforts to contain the Ebola virus in the city of Beni, according to Peter Salama of the World Health Organization. The rate of new cases doubled after containment efforts were halted by an attack last month.

10/19/2018

A study in The BMJ found that individuals who consumed the highest levels of seafood-derived docosapentaenoic acid had a 24% reduced risk of aging unhealthily, compared with those with the least consumption. Based on 2,622 adults from the Cardiovascular Health Study with an average age of 74, those in the top three DPA-consuming quintiles reduced their risk of experiencing unhealthy aging by up to 21%.

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Medical News Today
10/19/2018

Teva Pharmaceutical Industries' generic version of mifepristone was granted tentative approval from the FDA. The drug is the active ingredient in Corcept Therapeutics's Korlym.

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Seeking Alpha
10/19/2018

Mountain View, Calif.-based Beddr has announced the release of its FDA-registered consumer wearable, SleepTuner, which monitors a user's blood oxygen, heart rate, stopped breathing events, position, movement and awakenings during sleep using optical sensors and a three-axis accelerometer. The Bluetooth-enabled device, which is designed to be worn on the forehead, provides insights on how sleep quality can be improved and stores data in the Beddr Cloud until it syncs with the Beddr iOS mobile app.

10/19/2018

The FDA's Center for Devices and Radiological Health has released final orders down-classifying six new device types, including putting wound autofluorescence imaging devices in class I. The orders down-classify five device types into class II (special controls): the intranasal electrostimulation device for dry-eye symptoms, hemostatic device for intraluminal gastrointestinal use, the positive airway pressure delivery system, the thermal vestibular for headache and the light-based energy source device for topical application.

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Regulatory Focus
10/19/2018

Dublin, Ireland-based Allergan plans to submit a marketing application for its migraine therapy ubrogepant to the US early next year. Allergan recently finished two safety studies in which more patients treated with 50-mg and 100-mg doses of the drug experienced relief from pain and bothersome migraine-associated symptoms two hours after the initial dose, compared with those receiving placebo.

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Allergan, migraine
10/19/2018

An early-stage study was launched in China by Hutchison China MediTech, or Chi-Med, to assess the preliminary efficacy, safety and pharmacokinetics of its experimental drug HMPL-523, combined with azacitidine, as a treatment for elderly acute myeloid leukemia patients who have not been previously treated or who are ineligible to undergo standard induction therapy. The study's primary endpoint includes overall response rate as well as adverse events.

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Seeking Alpha
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AML
10/19/2018

Rocket Pharmaceuticals unveiled updated long-term results from a Phase I/II study being conducted in Spain to assess its gene therapy candidate RP-L102, indicated for patients with Fanconi Anemia, a rare, inherited hematologic disorder. The data were presented at the meeting of the European Society of Gene and Cell Therapy, which showed durable engraftment in four patients based on follow-up data for 12 months.

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Seeking Alpha
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Fanconi anemia, Rocket Pharma