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FDA Issues Guidance To Help Streamline Medical Device Clinical Trials

The U.S. Food and Drug Administration issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies. The Bayesian statistical method applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial. The combined data may provide sufficient justification for smaller or shorter clinical studies. "This final guidance on the use of Bayesian statistics is consistent with the FDA's commitment to streamline clinical trials, when possible, in order to get safe and effective products to market faster, " said FDA Commissioner Margaret A.

Possible 'Artificial Pancreas' For Children With Diabetes

Scientists in Cambridge have shown that an 'artificial pancreas' can be used to regulate blood glucose in children with Type 1 diabetes. A trial found that combining a real-time sensor measuring glucose levels with a pump that delivers insulin can boost overnight blood glucose control. The Lancet study showed the device significantly cuts the risk of blood glucose levels dropping dangerously low. In total, 17 children and teenagers with Type 1 diabetes took part in the study over 54 nights in hospital. Insulin dose based on real-time readings System lets blood glucose monitor 'speak' to insulin pump Individually, the glucose monitoring system and the insulin pump used in the study are both already widely used and commercially available.

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Frank Semcer Is First To Be Honored With Stevens' Award For Innovation And Entrepreneurship

At Micro Stamping headquarters in Somerset, New Jersey, it is largely what is not visible that gives the metal-forming company its edge in the highly competitive world of precision component manufacturing. Chairman Frank Semcer, Sr. '65, an alumnus of Stevens Institute of Technology, has built a global enterprise over the past three decades by reinventing costly and outmoded manufacturing processes through innovative engineering - and keeping his agile, multi-faceted manufacturing operation competitive in the toughest global markets. In recognition of his pioneering vision and business savvy, Semcer will be the first recipient of the university's newly created Award for Innovation and Entrepreneurship.

5.6 Million Contract For Heart Assist Device For Infants And Toddlers

Researchers at the University of Pittsburgh and their collaborators have been awarded a $5.6 million federal contract to pursue the continued development of an implanted ventricular assist heart pump for infants and small children with congenital or acquired heart disease. The project aims to provide much-needed access to the sophisticated technologies that have saved the lives of older heart failure patients. Harvey Borovetz, Ph.D., distinguished professor and chair of the Department of Bioengineering and a deputy director of the McGowan Institute for Regenerative Medicine, is the principal investigator of one of four projects that comprise the Pumps for Kids, Infants and Neonates (PumpKIN) Preclinical Program, a $23.

Novus Scientific Receives FDA Clearance For TIGR TM Matrix Surgical Mesh World's 1st Long-Term Resorbable Synthetic Mesh

Novus Scientific Pte. Ltd announced that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the TIGR™ Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness exists. TIGR™ Matrix Surgical Mesh is a 100 percent resorbable, synthetic matrix, knitted from two different resorbable fibers that degrade at different rates following implantation. This unique patented dual-fibre design provides an initial high strength / high stability configuration, with gradually increasing compliance over time as the product is resorbed. The macroporous structure is designed to allow tissue integration for reliable tissue repair.

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Artificial Pancreas Trials Show Benefits For Kids, Teenagers With Diabetes

In a landmark study in children and teenagers with type 1 diabetes, JDRF-funded researchers at the University of Cambridge showed that using a first-generation artificial pancreas system overnight can lower the risk of low blood sugar emergencies while sleeping, and at the same time improve diabetes control. The trials tested the safety and effectiveness of a first-generation artificial pancreas system used overnight in a hospital setting with participants between 5 and 18 years of age with type 1 diabetes. The system combined commercially available blood glucose sensors and insulin pumps, controlled by a sophisticated computer program that determined insulin dosage based on blood glucose levels while the participants slept.

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