Bionest

Changing Policies for Kidney Care

More than 1 in 7 American adults has chronic kidney disease (CKD), with the majority of those affected unaware of it. CKD is associated with heart disease, stroke, kidney failure and early death. Chronic kidney care for patients who have progressed to end-stage renal disease (ESRD) or kidney failure — and thus require dialysis —...

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FDA Fosters Innovation in Diabetes Care Through New Device Classification

Digital technologies are becoming an increasingly important part of modern healthcare. Medical devices  have the ability to connect to and communicate with other devices or systems. Not only are new types of devices being created, but many existing devices are being updated with digital capabilities. As a result, the U.S. Food and Drug Administration (FDA)...

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Differentiation Through Digital  

Digital technology is becoming increasingly important in the healthcare space. This was clearly reflected by the growing number of companies and events focused on the digital healthcare sector during JP Morgan/Biotech Week in San Francisco and new conferences dedicated to digital technology applications in health and wellness that have been scheduled for 2019. Uses of...

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New Options for Diabetes Therapy on the Horizon

Research presented in June at the American Diabetes Association (ADA) meeting highlighted potential advances for diabetes patients who use drugs in a class called incretin mimetics –specifically GLP-1 (glucagon-like peptide 1) agonists — to help control their blood sugar. Such drugs work by increasing the secretion of insulin from the pancreas, inhibiting glucagon (a hormone...

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Embryonic Stem Cell Technology and FDA

Stem cell research has elicited both excitement and controversy since its earliest days. Hematopoietic stem cell transplants have been employed for some time in the treatment of certain blood cancers. More recently, researchers have reported clinical successes in using bone marrow transplants to treat sickle cell disease as well as multiple sclerosis, where bone marrow...

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FDA Decision on Dexcom Device Changes Playing Field for Continuous Glucose Monitoring

At the end of March, the U.S. Food and Drug Administration approved a new continuous glucose monitor (CGM) system, the Dexcom G6. The new sensor is smaller than current CGM devices, about the size of a quarter. It comes already calibrated from the factory, thus freeing users from daily finger sticks. It is formatted as...