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Medical Edge November 13, 2012(Medical Design Via Acquire Media NewsEdge) View Web Version | Add to Safe Sender List Medical Edge News & Innovations for the Medical Device Community November 13, 2012 Diversity and three devices comprise Cleveland Clinic’s Top 10 for 2013Six months until FDA’s UDI rule; AdvaMed respondsBoston Scientific buys Vessix VascularSparton to buy OnyxArazy cloud-based device registration systemPressure switchesLight materials3D printer package for academiaThin-film Thermoelectrics in PCR Thermal Cycling Editorial Diversity and three devices comprise Cleveland Clinic’s Top 10 for 2013 By Joe Jancsurak, Editor A modular device for treating complex aneurysms; a handheld optical scanner for detecting melanoma; and an implantable almond-sized neurostimulator for battling cluster and migraine headaches are among the Cleveland Clinic’s Top 10 Medical Innovations for 2013. Now in its seventh year, the predictions are made by a panel of Cleveland Clinic physicians and researchers and are unveiled during a panel presentation on the final day of The Clinic’s three-day Innovation Summit (held last month on orthopedic technologies). FULL ARTICLE Articles Six months until FDA’s UDI rule; AdvaMed respondsAdvaMed last week provided its comments in response to the FDA proposed rule on implementing a unique device identification (UDI) system for most medical devices distributed in the US. The rule, scheduled to take effect in six months, would require implantable devices to carry unique numerical identifiers so products can be tracked through the distribution chain and once they are in use. It would also add medical devices to the Sentinel post-marketing surveillance initiative, a national, integrated electronic system that currently monitors prescription drug safety after FDA approval and marketing to patients. FULL ARTICLE Advertisement Boston Scientific buys Vessix VascularVessix Vascular, Inc, developer of a novel percutaneous radio-frequency balloon-catheter for renal denervation for the treatment of uncontrolled hypertension, has been acquired by Boston Scientific Corp, for $425 million. FULL ARTICLE Advertisement Pneumadyne's Miniature Precision Regulator Pneumadyne's Miniature Precision Regulator offers highly accurate air pressure control in a compact package; ideal for limited space applications. This high quality regulator features an output pressure range up to 100 psi and high flow rate of 4.5 scfm. With a maximum supply pressure of 250 psi, our Precision Regulator is extremely dependable and repeatedly returns to the set pressure when turned off and on. Exceptionally tight design tolerances effectively minimize vibration allowing the regulator to remain stable under changing operating conditions. www.pneumadyne.com Sparton to buy OnyxSparton Corp’s Sparton Onyx LLC unit, maker of in vitro diagnostic therapeutic and surgical devices, has agreed to buy Onyx EMS LLC for $43.25 million in cash. Onyx, with sites in both Watertown, SD, and Minneapolis, makes medical devices for OEM and emerging technology companies, including products for cardiovascular diagnostics, hearing assistance, patient temperature and warming, point-of-care diagnostics, and surgical equipment used in intraosseous medicine. FULL ARTICLE Arazy cloud-based device registration systemLeading regulatory affairs firm Arazy Group announced the launching of www.Licensale.com, a novel, cloud-based, online regulatory management system for compliance and licensing system for medical device manufacturers and national regulatory bodies. The system will provide an integrated platform for simultaneous registration in multiple markets and was presented this week at Medica 2012 in Dusseldorf, Germany. FULL ARTICLE Advertisement Deep-Drawn Components for Medical and Dental Applications Deep-drawn components that meet the high standards of the medical and dental industries. From implantable parts made of commercially pure Grade 1 or 2 titanium to nicely finished dental implant packaging components, Braxton's manufacturing expertise should be an essential element of your precision medical parts. Request your FREE sample kit today. New Products Pressure switches The H Series of pressure switches by Madison Company is designed for medical and other applications. The series include switches for ultra-low operating pressure ranges down to 0.04 in./H2O (0.25 psi). The differential switches allow for high operating pressures up to 5,000 psi. Vacuum switches are designed to stand up to extended duty applications. FULL ARTICLE Light materialsUltraLite Foil product line by Ulbrich includes stainless, nickel, titanium, and special metals alloys. Defined as 0.0015-in. and under, the UltraLite Foil products are for the medical, electronic, and aerospace industries. The company’s technology is dedicated to foil and light gauge materials. FULL ARTICLE 3D printer package for academiaThe Objet30 Scholar an all-inclusive 3D printing package for schools, colleges, universities was announced by Objet Ltd. The system provides students and faculties across multiple disciplines particularly STEM curriculum studies with increased opportunities to create and prototype advanced design ideas. Tailor-made 3D printing solutions for the education market are a strategic objective of Objet. The company’s 3D Printers have been adopted by universities and research departments at Virginia Tech, University of New Orleans, Art Center College of Design (Pasadena, CA), Purdue University, and The Technion (Israel). FULL ARTICLE Free Resources Thin-film Thermoelectrics in PCR Thermal CyclingRapid thermal cycling is becoming increasingly important as PCR becomes more widely used in point-of-service, field-level applications. New applications pushing for portability and reduced analysis time offer the promise of large new markets beyond the traditional laboratory and academic settings. In order to meet these requirements, Nextreme Thermal Solutions has developed a compact thermal cycler reference design based on the microscopic size and fast response time of thin-film thermoelectrics. Thin-films enable a new generation of compact thermal cyclers that feature significantly shorter throughput times, smaller sample sizes, and reduced footprint for real-time testing in healthcare, forensics, and food safety. 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