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FDA has set in motion two new training programs designed to improve the consistency of medical device reviews “by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH),” the agency says.
The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH’s Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, launched in September and is intended to include all new device reviewers.
The program includes up to 18 months of training, aimed at complementing the skills and knowledge that new reviewers bring to CDRH from fields such as biomedical engineering and healthcare. Reviewers in the program will complete online training modules, instructor-led courses, and obtain practical experience in the medical device review process. Courses include medical devices, food and drug law and regulatory requirements, the CDRH review process, device design, and the impact of human factors.
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In a continued mission to reduce the global burden of noncommunicable diseases (NCDs) such as cardiovascular disease and diabetes, Medtronic Inc and the Medtronic Foundation today announced a new commitment designed to improve healthcare systems and increase access to life‐saving therapies. In addition to the company’s focus on improving access to critical medical technologies in lower‐ and middle‐income countries, the commitment includes an additional $3.4 million in Medtronic Foundation grants to support international health programs specifically designed to address prevention, treatment and control of NCDs. Medtronic is focusing activities in three primary areas: global policy and advocacy, strengthening health systems and developing innovative therapies, and healthcare delivery models in countries around the world.
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The Society of Laparoendoscopic Surgeons (SLS) has selected Starion Instruments’ MiSeal reposable thermal ligating system as one of its 2011 Innovations of the Year. The award was presented at the opening ceremony of the 20th SLS Anniversary Meeting and Endo Expo, Sept 14, in Los Angeles. Launched in March 2011, Starion’s MiSeal is the first and only reposable device that simultaneously seals and divides soft tissue and vessels using direct thermal energy, offering surgeons the ability to achieve exceptional patient outcomes at a considerable cost advantage. MiSeal is comprised of a reusable handpiece and a disposable tip. Because it is reposable, MiSeal offers cost-effective, ecofriendly benefits compared with fully disposable devices because it can reduce the disposal cost of biohazardous waste. This marks the third time that one of Starion’s products has been chosen for this prestigious award, which recognizes the most innovative products of the past year that have a multidisciplinary application in minimally invasive surgery.
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Tekscan Inc has earned a ranking on the 2011 Inc. 5000, the business magazine’s annual listing of the fastest-growing private companies in America. Tekscan, which manufactures tactile pressure and force measurement systems and sensors, has achieved more than nine consecutive years of revenue growth and has more than doubled its revenue since 2004, according to the company. Notably, between 2007 and 2010, the company grew 40%. Tekscan also increased its staff level by 24% during this timeframe, which the company says is a testament to Tekscan’s ability to grow and prosper, despite periods of economic uncertainty. Tekscan says that because of its solid financial standing, it has been able to dedicate significant resources and money to invest in itself through expanded research and production capabilities.
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A newly designed 70-W flat brushless motor delivers a maximum continuous torque of 130mNm at an efficiency of up to 85%. The Maxon motor in its 45mm diameter is available with Hall sensors and comes in four windings (24, 30, 36, and 48V). It can be combined with more than 54 different planetary and spur gearheads. For motion control purposes, a wide variety of servo controllers and positioning controllers are available to select from. Designed as internal or external rotor motors, the design of the brushless dc flat motors are often the ideal solution when space is limited.
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New High Rate Lithium Ion Cell Ideal for Medical Equipment
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 Panasonic, one of the world's leading battery manufacturing companies, has introduced a new high rate lithium ion cell. The CGR18650CH is ideal for medical equipment, hand-held tools, memory storage and backup power applications. The cell’s Nickel Manganese-based cathode material delivers higher discharge rates and better energy density and voltage than comparative cells. Other features include wide operating temperature range and excellent cycle life. Click for detailed technical information.
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Low dropout regulators (LDOs) feature a high PSRR of 70dB at 1kHz (typical) and a maximum output current of 150mA at +125°C junction temperature. the Microchip MCP1754/MCP1754S LDOs offer a high input voltage of 16V and an output voltage range from 1.8 to 5.5V, with standard output voltages of 2, 2.5, 2.8, 3, 3.3, 4, and 5V, and output voltage tolerances of ±2.0% \over the entire temperature range. The MCP1754 provides enhanced features, such as a shutdown input signal and a power-good output signal, while the MCP1754S is the baseline version of the device.
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A software framework is designed to offer developers more options with an integrated hardware and software infrastructure. Eurotech has launched release 1.4 of its Everyware Software Framework. ESF 1.4 provides a new Web GUI configuration application that manages the networking interfaces such as cellular or Wi-Fi. It offers the connectivity and security required for machine-to-machine and embedded solutions. Along with the configuration capabilities, the ability to run ESF on different hardware systems means developers who write applications on the ESF framework can do so as quickly as possible, while future-proofing their development. The latest release incorporates additional industry standard interfaces to shorten custom development time and simplify coding, debugging, and even connecting to a network, according to the company.
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Hybrid Technology Powers Integrated Connectors
The Mini Hybrid Connector integrates air lines and electronics into a compact, single connection point for remote tools on medical devices and equipment, reducing misconnections and enhancing patient therapy outcomes.
www.colder.com
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.
www.bokers.com/mee
What the heck is a hexa-kaleidocycle?
It's Protogami, a 3-dimensional folding object that showcases the interaction of materials and surface finishes—the newest, interactive design aid from Proto Labs. You'll learn, you'll be endlessly amused, and you just might be inspired to come up with the next big thing. Request a no cost Protogami today.
Bishop-Wisecarver Corporation
For easier application integration, a new track support is available for MinVee® Linear Slides – axial load capacities up to 121 lbs and speeds up to 5 m/s.
www.bwc.com
Phillips Plastics Corporation®
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.
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