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Medical Edge September 14, 2010

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September 14, 2010





IP + NDA = MSC
By Joe Jancsurak, Editor

Intellectual property (IP) and non-disclosure agreements (NDAs) will be featured topics at the Medical Silicone Conference (MSC), Nov. 3-4, at the Sheraton Park Anaheim Resort . . . hence, the headline.

Full Article


Articles



InHealth grants target 510(k) process and implantables;

InHealth’s board of directors has approved two follow-on grants totaling more than $830,000 for studies by faculty teams at Northwestern University and Duke University. Northwestern investigators will study opportunities for improving FDA’s 510(k) product review process. The work builds on their previous InHealth-funded research that for the first time documented in detail the medical technology development process.

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Advertisement

Apple Rubber offers expanded line of medical-grade
elastomer seals and O-rings.

In addition to popular Silicone, Apple Rubber now offers custom O-rings and seals made from medical-grade elastomers such as Viton® fluoroelastomer (FKM) and EPDM rubber. Ideal for medical applications, such elastomers feature improved chemical resistors, excellent heat resistance (400°F/200°C), and low permeability to gases. Capabilities at Apple Rubber include complete engineering support, manufacturing, quality assurance and a Class 10,000 ISO Class 7, certified cleanroom.




US/Japan ‘OSPREY’ seeks to streamline product approval process

The Bradenton (FL) Cardiology Center is the first center in the US to implant the MISAGO Peripheral Self-expanding Stent System as part of the Occlusive/Stenotic Peripheral artery REvascularization StudY (OSPREY), which will evaluate the safety and efficacy of the MISAGO Stent System for use in the superficial femoral artery (SFA). The OSPREY clinical trial will simultaneously enroll patients in the US and Japan.

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White papers: valves, piezo, cable

Parker Hannifin’s white paper, “Benefits of Using a High Flow Proportional Control Valve,” discusses achieving high flow in miniature proportional valves while keeping size, power, and cost demands to a minimum. • PI (Physik Instrumente) Ceramic’s white paper, “Development of Highly Reliable Multilayer Piezo Actuators and Lifetime Tests Under DC and AC Operating Conditions,” describes the development and lifetime tests of ceramic encapsulated actuators under ac and dc operation conditions. • W.L. Gore & Associates’ white paper, “Selecting the Right Cable System for Your Environment,” covers the electrical, mechanical, environmental, and application- specific constraints that will affect cable performance.

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New Products



Actuator for finer positioning

The 19000 series high-resolution linear actuator by HaydonKerk, Waterbury, CT, is a 20mm-diam can-stack offering with a 7.5° step angle, resulting in smaller move increments and finer positioning ability.

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Electrosurgical device testing

Testing of electrosurgical (monopolar and bipolar) active accessories and cables by DDL, Minneapolis, is used to support 510(k) submissions and to justify CE marking. Until a few years ago, ANSI/AAMI HF18 was the most widely used standard for electrosurgical accessories in the United States.

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Shafting for smoother motion

LinearRace shafting by Thomson Industries, Inc, Wood Dale, IL, is 65% lighter than typical linear shafting, resulting in smooth and easy linear motion positioning for plan-bearing applications. The non-magnetic material is well-suited for use in medical imaging applications.

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News from Medical Design




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