By Sherrie Conroy
Senator Dan Coats (R-Ind.) has introduced legislation to clarify and reform the mission of FDA in order to promote job creation. The FDA Mission Reform Act (S. 1972) would require FDA to establish a predictable, consistent, and transparent regulatory environment. "The current regulatory environment created by the FDA has forced American companies to eliminate jobs and move operations overseas," says Coats. "Unpredictable and burdensome regulations from this agency have severely impacted medical device manufacturing, an important industry in Indiana's economy. These are tough economic times, and we need to support, not punish, our job creators so they can innovate and expand. This legislation will encourage the development of innovative products and protect American jobs."
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Articles
GE Healthcare and Microsoft Corp. have announced plans to create a joint venture aimed at helping healthcare organizations and professionals use real-time, system-wide intelligence to improve healthcare quality and the patient experience. Upon formation, the new company will develop and market an open, interoperable technology platform and innovative clinical applications focused on enabling better population health management to improve outcomes and the overall economics of health and wellness.
According to the companies, this new venture will combine Microsoft's deep expertise in building platforms and ecosystems with GE Healthcare's experience in clinical and administrative workflow solutions. The idea is to empower healthcare professionals and organizations with the intelligence and capabilities to respond to the rapidly evolving and complex healthcare landscape.
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WellDoc, a healthcare company that develops technology solutions aimed at engaging patients and enhancing health outcomes, has announced results showing that Type 2 diabetes patients who used its WellDoc DiabetesManager in a demonstration project significantly reduced their need for hospital stays and emergency room (ER) visits. The demonstration program, titled DC HealthConnect, was part of the Chronic Care Initiative sponsored by the DC Department of Health (DOH) and was conducted by the George Washington University Medical Center under the supervision of Richard J. Katz, MD. According to the company, patients using the WellDoc DiabetesManager for an average of 12 months reduced their ER visits and hospital stays by 58% compared to the 12 months prior to the program.
WellDoc DiabetesManager is the first clinically tested and FDA-cleared mobile health (mHealth) solution to provide automated, real-time behavioral patient coaching and clinical decision support.
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New Whitepaper Addresses Fluid Systems in Medical Equipment
Gems Medical Science brings you a new, informative whitepaper entitled, "Fluid Handling in Medical Device Design: Issues and Challenges". Written for engineers of medical diagnostic equipment incorporating fluid systems. Topics include the consolidation and simplification of systems, reduction in size and weight, cost control, outsourcing design and manufacturing functions, reducing development time, streamlining risk and data management, value engineering, and improving cost-efficiency.
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Integra LifeSciences Holdings Corp. has opened its first Asia business office in Shanghai, China, as part of an ongoing expansion to serve one of the world's fastest developing medical device markets. Stuart Essig, Integra's CEO, officiated at the grand opening ceremony of the office, which is located at the People's Square area of Huangpu District. Dignitaries from the Shanghai Food and Drug Administration (SFDA), relevant governmental departments, Integra employees, and members of the local media attended the event.
"China's rapidly growing economy has created a significant medical device market that presents Integra with major growth opportunities," says Essig. "This is an important milestone for our company and a clear indication of the importance we place in the area."
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New Products
Compact limit switches feature 35mm wide die-cast housings. Automation Direct has expanded its limit switch line to include the AEM2G series compact limit switches. The switches are equipped with one normally open and one normally closed contact; all units include a three-meter cable. The IP67-rated series utilizes standard 25mm hole spacing.
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Design engineers looking for a faster, smarter way to specify and select high-reliability transformers and inductors for electronic equipment applications can access the new Magnetics Selection Guide & Short Form Catalog from Datatronic Distribution, Inc. and Datatronics Romoland, Inc. The new Selection Guide & Short Form Catalog provides specification information on dozens of transformers and inductors.
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Precision Tool and Die offers overmolding of radiopaque marker bands. The thin‐walled metal tubes can be placed at strategic locations on a catheter for visibility under an x‐ray fluoroscope. The bands are typically made from a high density metal such as platinum, gold, or tantalum. Over molding the marker band enables a reduction of overall assembly cost and precision location of the band. In addition, the marker band is completely sealed from the environment.
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Featured Links
Boker's 2011 Washer Catalog
Boker's 2011 Washer Catalog features over 25,000 non-standard flat washer sizes, available with no tooling charges, outside diameters of 0.080" to 5.140" and over 2,000 material options for endless possibilities.
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Phillips Plastics CorporationŽ
Medical OEM projects often require more that a custom part or a vendor with limited services. Learn more about the engineering services, materials support, clean rooms, quality control, packaging, sterilization, manufacturing technologies available from Phillips Plastics.
2012 PROTO LABS CALENDAR
Designed by designers and engineered for engineers, our annual Cool Parts Calendar features the visions of product developers across the nation and around the world. It features monthly contests, industry tradeshow dates, and (of course) those elusive days of the week. Request your calendar today.
Bishop-Wisecarver Corporation
LoProŽ actuated linear guides provide smooth and quiet actuation, making it the perfect choice for clean room, medical and laboratory application environments. www.bwc.com
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