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Phillips smartsleep fda4/14/2023 “We’re honored to have the SmartSleep Deep Sleep Headband selected for these studies that will be important not only for space exploration, but also for the millions of people who have difficulty obtaining adequate sleep,” said John Frank, Business Leader, Sleep and Respiratory Care at Philips. Philips’ technology is the first-of-its-kind to be used in this type of research. The two-year initiative will use the Deep Sleep Headband to determine if sleep can be improved during deep space exploration by utilizing a variety of auditory stimulation protocols, thereby maximizing cognitive function. Photo: courtesy of Koninklijke Philips N.V. Image: SmartSleep Deep Sleep Headband explores sleep in space. This content was issued through the press release distribution service at Philips has announced that the company’s SmartSleep Deep Sleep Headband will be used in research funded by the Translational Research Institute for Space Health (TRISH), a virtual institute empowered by the NASA Human Research Program, for two unprecedented studies evaluating the relationship between sleep and cognitive performance for behavioral health. GENinCode operates business units in the UK, in the United States through GENinCode U.S. Cardiovascular disease is the leading cause of death and disability worldwide. GENinCode Plc is a UK-based company specialising in genetic risk assessment of cardiovascular disease. By 2030, the global cost of CVD is set to rise from approximately US$863 billion in 2010 to US$1,044 billion and is both a major health issue and global economic burden.Īnna Dunphy / Paul McManus / Louise GENinCode CVD accounts for an estimated 17.9 million deaths globally each year and accounts for one in every four deaths in the United States. GENinCode specialises in polygenic risk assessment of CVD, the leading cause of death and disability worldwide. CVD is a broad disease classification that encompasses conditions such as coronary artery disease (causing angina, heart attack and heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischaemia, and some chronic kidney disease) and venous thromboembolism. We are well placed to improve the CVD standard of care by identifying individuals at high genetic risk who can be advised on lifestyle choices and access to personalised treatment to improve future health outcomes.” Recognition of inherited genetic contribution to the onset of cardiovascular disease continues to grow. regulatory approval pathway and ongoing preparation for the launch of Cardio inCode-SCORE later this year. Matthew Walls, CEO of GENinCode Plc, said: “Despite the delays driven by the pandemic, the filing of the Cardio inCode FDA Pre-Submission marks the start of the U.S. It is an interactive process designed to give the opportunity to obtain FDA feedback on the application with the goal of making the end submission process more efficient. The FDA views Pre-Submission as a structured process for managing and tracking interactions between manufacturers and the FDA about the application for approval or clearance, prior to final submission. market approval, which is anticipated later this year. This marks the commencement of the regulatory pathway for U.S. Cardio inCode-SCORE is an in-vitro diagnostic test that assesses an individual’s combined genetic and clinical risk to predict and prevent cardiovascular disease (“CVD”).įollowing extensive exchange of information and constructive discussions with the FDA, GENinCode has been invited by the FDA to file its Pre-Submission for Cardio inCode-SCORE. 11 (Korea Bizwire) – GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces the filing of its Pre-Submission for Cardio inCode-SCORE with the Food and Drug Administration (FDA).
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