Category: Regulations
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FDA Clears Asthma/COPD Mobile Reporting, Analytic System
6 May 2014. Propeller Health in Madison, Wisconsin says the U.S. Food and Drug Administration cleared the latest version of its mobile-device system to record and track maintenance therapy for patients with respiratory diseases, such as asthma and chronic obstructive pulmonary disease or COPD. The new version of the system cleared by the FDA, says…
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Alzheimer’s Brain Stimulation Implants Completed for Trial
30 April 2014. A clinical trial testing the safety and potential benefit of deep brain stimulation to treat Alzheimer’s disease completed implanting stimulation devices in enrolled patients in the U.S. and Canada. Functional Neuromodulation Ltd, in Toronto and Charlottesville, Virginia says it expects to report the first results from the trial in the second quarter…
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Tablet App Provides Feedback, Improves Drug Adherence
29 April 2014. Computer scientists at Carnegie Mellon University in Pittsburgh designed and tested a tablet app, connected to electronic sensors on a pillbox, that provides feedback to older adults and helps them stick to their medication schedules. Anind Dey, a professor in Carnegie Mellon’s Human-Computer Interaction Institute, and former Ph.D. student Matthew Lee, now…
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FDA Approves Intermediate ALS Stem Cell Clinical Trial
28 April 2014. BrainStorm Cell Therapeutics, in New York and Israel, says the U.S. Food and Drug Administration approved its beginning an intermediate stage clinical trial of a stem cell-based therapy for amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease. The trial will test for safety and tolerability of the company’s treatments…
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FDA Proposes Accelerated Medical Device Approval Process
23 April 2014. The U.S. Food and Drug Administration proposed yesterday a change in its approval processes for devices that meet unfilled treatment or diagnostic needs of patients with serious medical conditions. The Expedited Access Pre-market Approval Application, says the agency, is designed to speed not only the approval of new medical devices, but also…
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Most Americans Favor Contraceptives Required in Health Plans
22 April 2014. A nationwide survey shows about 7 in 10 Americans support birth control medications being required in health insurance plans. The survey, conducted in November 2013 by a team at University of Michigan at Ann Arbor is reported today online in the Journal of the American Medical Association. The Affordable Care Act includes…
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Football Head Hits May Need More Than Off-Season to Heal
17 April 2014. Researchers at University of Rochester in New York found college football players may need more than the standard six months from the end of one season to the start of the next for their brains to recover from blows to the head. The team led by Rochester’s Jeffrey Bazarian, a professor emergency…
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Early Trial Shows Immunotherapy Evidence With Some Tumors
16 April 2014. A clinical trial of a cancer vaccine developed by biopharmaceutical company Celldex Therapeutics Inc. in Hampton, New Jersey shows it generated an immune response which affected the growth of tumors in some patients with advanced stages of cancer. The early-stage trial, conducted with researchers from seven university or research institute labs appears…
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Blood Glucose Control Drug Approved for Type 2 Diabetes
15 April 2014. The U.S. Food and Drug Administration approved the drug albiglutide to help adults with type 2 diabetes control their blood glucose levels. Albiglutide is marketed in the U.S. under the brand name by Tanzeum by the global pharmaceutical company GlaxoSmithKline. Diabetes is a chronic condition where the pancreas does not create enough…
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Microparticle Solution Devised to Identify Genuine Goods
14 April 2014. Engineers at Massachusetts Institute of Technology and the affiliated Lincoln Laboratory developed a process for adding minute particles into materials that can be encoded and sensed by inexpensive readers to detect counterfeit goods from the originals. The team from the lab of chemical engineering professor Patrick Doyle published its findings yesterday online…