Archives: 2019-05-21

GE Healthcare announces commercial launch of Chronicle™ automation software for cell therapy

GMP compliant software specifically designed for cell therapy manufacturing from process development through commercialization Digital optimization for increased productivity and improved process control  GE Healthcare builds on its digital capabilities with the Chronicle web application, the next generation development of my Cryochain™ software now supporting the complete cell therapy workflow. Chronicle automation software is a

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Exercise and antioxidants: A winning combination for brain health?

An international team of researchers representing several institutions in Japan and the US has published promising findings that may stand to benefit people living with the specter of Alzheimer’s and other neurodegenerative diseases, as well as age-related cognitive decline. In their paper published in PNAS, “Leptin in hippocampus mediates benefits of mild exercise by an antioxidant

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Artificial Intelligence in Health Care Will the Value Match the Hype?

Source: JAMA Artificial intelligence (AI) and its many related applications (ie, big data, deep analytics, machine learning) have entered medicine’s “magic bullet” phase. Desperate for a solution for the never-ending challenges of cost, quality, equity, and access, a steady stream of books, articles, and corporate pronouncements makes it seem like health care is on the

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Study shows AI improves accuracy of lung cancer diagnosis

One of lung cancer’s most lethal attributes is its ability to trick radiologists. Some nodules appear threatening but turn out to be false positives. Others escape notice entirely, and then spiral without symptoms into metastatic disease. On Monday, however, Google unveiled an artificial intelligence system that — in early testing — demonstrated a remarkable talent

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5G In Healthcare

Source: TMF The next telecommunication revolution is just around the corner: the promises of high bandwidth, low latency and low-power-low-cost of 5G will open the gate to a flood of new inventions and the implementation of ideas, which have already been for long in the public consciousness – such as stable augmented reality or truly

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Update On FDA’s Comprehensive Regenerative Medicine Policies And Enforcement Activities

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by obtaining investigational new drug applications (INDs) and working towards premarket approval of their products. Recent public statements by FDA officials reiterating

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Athersys Announces Fast Track Designation From FDA for MultiStem® Program for Acute Respiratory Distress Syndrome

Athersys, Inc. (Nasdaq: ATHX) announced today that its clinical program evaluating MultiStem® cell therapy for the treatment of Acute Respiratory Distress Syndrome (“ARDS”) has received Fast Track designation from the United States Food and Drug Administration (“FDA”). This important designation is given to qualified investigational therapies that show promise in providing benefit to patients in

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