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  • Anouk Lorie 1:27 pm on August 6, 2014 Permalink
    Tags: bna analysis system, brain activity analysis, brain function, , FDA, food and drug administration approval, , ronen gadot,   

    EIMindA’s BNA Analysis System Receives FDA Approval 

    EIMindAAugust 6, 2014 | Israeli brain research company EIMindA announced that the United States Food & Drug Administration (FDA) has cleared the company’s BNA Analysis System for the assessment of brain function. The Brain Network Activity combines non-invasive, multi-channel EEG technology with signal processing and analysis algorithms to assess brain activity during certain processes. The system is then able to take the data it collects and provide both quantitative and qualitative insights into brain functionality. “Greater understanding of how our brain processes information, how it gets its job done, ultimately holds the potential to improve brain health and disease management over a person’s lifetime,” said Ronen Gadot, CEO of EIMindA. EIMindA was founded in 2006 to address an unmet need in the accurate, objective diagnosis and treatment of brain-related disorders through a data-driven approach.

  • Anouk Lorie 1:42 pm on July 30, 2014 Permalink
    Tags: cloud-based solutions, , diabetes management, FDA, , , italy, labstyle, ministry of health, new zealand, smarthpones, ,   

    LabStyle’s Dario Nabs Ministry Of Health Approval In Israel 

    LabStyle Innovations Raise $4.19M In Private PlacementJuly 30, 2014 | Israeli company LabStyle received approval from Israel’s Ministry of Health for its Dario smart meter for diabetes. Dario was launched in late March of this year in the United Kingdom, Italy and New Zealand and has already filed an application for US Food & Drug Administration approval. According to LabStyle, the company hopes to expand the marketing of Dario to six more territories by the end of 2014. LabStyle’s Dario is a cloud-based diabetes management solution, allowing diabetics to monitor their blood sugar and other aspects of the disease from their mobile devices or smartphones.

  • Anouk Lorie 1:18 pm on July 30, 2014 Permalink
    Tags: avian flu, , deadly flu, FDA, H7, , m-001, , ,   

    Positive Results For BiondVax’s Avian Flu Vaccine 

    BiondVax To Receive €500,000 Grant From EUJuly 30, 2014 | The developer of the universal flu vaccine BiondVax announced that it has completed studies which validate the effectiveness of a vaccine against the deadly H7 avian flu virus. The H7 avian flu strain is highly contagious, infecting 76 percent of people and killing 33 percent on average. Studies were recently released confirming the viability of BiondVax’s M-001 vaccine, the universal flu vaccine, against two strains of avian flu, H5 and H7. In line with Food & Drug Administration standards in the United States, BiondVax’s M-001 vaccine doubled the chances of adequate protection against contracting H7 in mice studies. BiondVax, a publicly traded company,  has a team of 14 scientists devoted to developing their breakthroughs in vaccination at its headquarters in the Weizmann Institute of Science Park in Nes Tziona, Israel.

  • Anouk Lorie 12:31 pm on July 15, 2014 Permalink
    Tags: albuterol, asthma, FDA, inhaler, mdpi, multi-dose, teva pharm, us fda   

    FDA Set To Review Teva’s Asthma Rescue Inhaler 

    Teva Makes $149M Offer For American Company NuPatheJuly 15, 2014 | The US Food and Drug Administration (FDA) is set to review Teva Pharmaceutical Industries‘ drug application for the treatment of asthma, the albuterol multi-dose dry-powder inhaler (MDPI). According to a “Globes” report, the inhaler will be used to treat patients of 12 years of age or older for bronchospasm. Teva VP of Global Respiratory R&D Tushar Shah said, “If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients. As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.”

  • Anouk Lorie 12:18 pm on July 6, 2014 Permalink | Reply
    Tags: , FDA, , healthcare tools, hospitals, monitoring chair,   

    EarlySense Nabs FDA Approval For Its Monitoring Chair 

    Israeli Patient Monitoring Systems Company EarlySense Raises $15MJuly 6, 2014 | The Israeli creator of a hospital bed monitoring device EarlySense received U.S. Food & Drug Administration approval for its monitoring chair. FDA approval will allow the company to market the device to hospitals throughout the United States. EarlySense is an Israeli company with offices in Israel and the U.S. that markets sensors for hospital beds, especially those to help patients connected to many monitoring devices. The sensor is placed under the hospital bed mattress and works by sensing changes in pressure caused by the patient moving in the bed, alerting hospital staff of sudden movements or changes, like when a patient falls out of bed.

  • Anouk Lorie 11:58 am on July 1, 2014 Permalink | Reply
    Tags: , , FDA, , , , , ,   

    Report: Developer of ReWalk, Argo To Raise Up To $50M On Nasdaq 

    ReWalk Developer Argo To Hold $60M IPO On NasdaqJuly 1, 2014 | The developer of the ReWalk exoskeleton, Argo Medical Technologies, will attempt to raise $40-50 million on Nasdaq at a company value of $250-300 million, according to a “Globes” report. Earlier this week, the ReWalk exoskeleton, designed to help paraplegics and quadriplegics usually confined to wheelchairs walk again, was approved by the Food & Drug Administration (FDA) in the United States for use at home and in the community. Argo Medical Technologies was founded by Dr. Amit Goffer in 2001 and quickly grew from a small startup based in Israel to an international company with offices in the US, Germany and Israel.

  • Anouk Lorie 12:33 pm on June 29, 2014 Permalink | Reply
    Tags: , , FDA, , , , ,   

    ReWalk Walking Device For Paraplegics Granted FDA Approval 

    ReWalk Developer Argo To Hold $60M IPO On NasdaqJune 29, 2014 | The ReWalk exoskeleton, a device that helps paraplegics walk, announced that its life-changing device was certified by the FDA in the United States. The device, which straps on to the user’s legs and involves the use of crutches to allow those usually confined to wheelchairs to traverse various indoor and outdoor environments, costs about €52,500 ($72,000) in Europe. The US pricing for the device has yet to be revealed. The ReWalk device was created in 2011 by Israeli company Argo Medical Technologies’ founder Dr. Amit Goffer, who himself is a quadriplegic.

  • NoCamels Team 1:14 pm on September 10, 2013 Permalink | Reply
    Tags: acute myeloid leukemi, , , FDA, orphan drug,   

    BioLineRX Wins FDA Orphan Drug Status For Rare Leukemia Treatment 

    BioLineRX Wins FDA Orphan Drug Status For Rare Leukemia TreatmentIsraeli phramaceutcial company BioLineRX has won FDA approval for its BL-8040 acute myeloid leukemia treatment. The drug was given orphan drug status, which is given to treatments for conditions suffered by less than 200 thousand people in the US.

    Following the approval, BioLineRX will have seven years to market the drug exclusively in the US.

  • NoCamels Team 1:14 pm on August 13, 2013 Permalink | Reply
    Tags: , , FDA, ,   

    Given Imaging Wins FDA Approval For Next-Gen PillCam 

    Given Imaging Wins FDA Approval For Next-Gen PillCamIsraeli company Given Imaging, which develops pills mounted with cameras to replace endoscopies, has announced that it has won the US Food and Drug Administration’s clearance for its next generation PillCam.

    The new PillCam, SB 3, detects and monitors small bowel abnormalities associated with Crohn’s disease, obscure gastrointestinal (GI) bleeding and iron deficiency anemia.

  • NoCamels Team 1:02 pm on July 29, 2013 Permalink | Reply
    Tags: , chinese, exablate, FDA,   

    InSightec’s ExAblate Wins Chinese FDA Approval 

    InSightec's ExAblate Wins Chinese FDA ApprovalIsraeli company InSightec, which develops MR guided Focused Ultrasound therapy, announced that its ExAblate system received approval of the Chinese Food and Drug Administration (CFDA) for non-invasive treatment of uterine fibroids.

    ExAblate combines high intensity focused ultrasound waves and continuous MRI guidance and monitoring. The focused ultrasound energy is used to ablate or destroy the fibroids while the MRI images are used to plan and guide the therapy and monitor treatment outcome.

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