By Sherrie Conroy
Sen. Al Franken (D-MN) yesterday visited Medtronic in Mounds View, MN. The senator met with several hundred company officials and employees to discuss legislation he plans to propose to get innovative medical devices to market more quickly and safely.
Sen. Franken’s bill would promote the development of devices to treat patients with rare diseases and would help improve the FDA approval process for medical devices by allowing the agency to more easily consult with experts. The legislation would also lift the current profit cap on all medical devices that receive FDA exemptions that allow the product to get to market much faster.
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Medtronic, Inc and Bain Capital, a global private investment firm, have entered into a definitive agreement under which affiliates of Bain Capital will acquire Physio-Control, which makes emergency medical response technology for use in the intervention and treatment of cardio-respiratory and other medical emergencies. The stock of Physio-Control and related entities will be purchased for cash in a transaction valued at approximately $487 million.
According to Medtronic, it expects to use a portion of the proceeds to offset any potential dilutive impact from this transaction to fiscal year 2012 non-GAAP earnings per share. Headquartered in Redmond, WA, Physio-Control has nearly 1,000 employees worldwide. Brian Webster, currently president, will continue to lead the company and will be named chief executive officer following completion of the transaction.
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 High Resolution Vision System for Medical Device Applications
The 5 megapixel In-Sight 5605 vision system combines industrially rugged hardware and best-in-class vision tools with a high resolution imager for the ultimate standalone vision system. The In-Sight 5605 system is ideal for high accuracy defect detection, gauging and ID reading applications. It's equipped with a full library of proven Cognex vision tools through the easy to use In-Sight Explorer software. Tools include code reading, OCR, inspection, measurement and color tools plus, PatMax®, the industry standard for part location technology. www.cognex.com
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Covidien, maker of mechanical ventilation and respiratory care devices, has received the American Association for Respiratory Care (AARC) Zenith Award for 2011.
“Covidien is honored to receive acknowledgement that our offerings bring true value to respiratory care professionals and help provide insight into respiratory care cases,” says Robert J. White, president, Respiratory and Monitoring Solutions, Covidien. “This award reflects our commitment to delivering unparalleled product innovations and high-quality service to benefit respiratory patients.”
The Zenith Award, established in 1989, recognizes manufacturers and service organizations in the respiratory care industry for outstanding service. The award is presented to five companies annually on behalf of AARC’s 52,000 members.
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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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A new device is set to change a horrible statistic: 12.9 million babies are born too soon every year, and 1 million of those babies die. The United States has the second highest rate of prematurity (1 of 8 babies) in the world. The CerviLenz device will help reduce those staggering numbers. Prematurity is a $26.2 billion problem in the US annually. The company expects the device to play a vital role in finding high-risk pregnant women for preventive treatment.
Cervilenz Inc recently introduced its novel CerviLenz device to the obstetrics market. The CerviLenz device measures cervical length to help doctors identify and manage pregnant patients who are at high risk of premature delivery. According to CerviLenz, there is now conclusive evidence that vaginal progesterone treatment for women diagnosed with a short cervix reduced their rate of prematurity by 45%. Contract manufacturer Interplex Medical, LLC helped design and manufacturers the device.
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New Products
Omnexus.com, a community that provides plastics and elastomers solutions, has partnered with Sabic Innovative Plastics (Riyadh) to offer educational content on resins designed for use in the medical market. The content highlights the Sabic’s Ultem HU1004 PEI Resin, which has multiple sterilization capabilities that enable the development of cleaner, safer materials.
Providing cleaner and safer devices and instruments to medical professionals and patients is a key differentiating factor for OEMs and designers. According to Omnexus, intimately tied to providing such devices is the ability of the base plastic resin to deliver long-term performance, even after multiple and varied sterilization procedures.
Identifying the best material to meet this criterion is now an easy task, thanks to the new medical grade of Ultem* Polyetherimide (PEI) resin.
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Interface Catheter Solutions announces a new balloon visual inspection system with upgrades that can significantly reduce cycle times. The Auto-i 360 system provides both visual/flaw inspection and dimensional measurements of medical balloons in a single operation to add consistency and accountability to the inspection process. Inspection includes classification and size of defects with pass/fail analysis based on user-selected criteria. The balloon visual inspection system operates with a sophisticated vision system and analysis program with an intuitive user interface. The system provides immediate detailed visual and data reporting used in both quality manufacturing inspection and research and development. The Auto-i 360 has a faster processor and camera lens with a higher level magnification for accurately measuring all dimensional aspects of the balloon and the smallest of flaws.
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Solvay Specialty Polymers USA, LLC, has standardized the color range of its Radel polyphenylsulfone (PPSU) resins, offering a range of standard opaque colors for the healthcare industry. The Radel PPSU is used for demanding reusable applications, including medical and dental instruments, sterilization cases, trays, and lids, and medical equipment.
The company says the resins can provide unique branding opportunities for medical OEMs, as well as a quick visual reference for to help healthcare professionals with identifying instrument types and sizes. The company introduced the standard colors in response to market demand for PPSU products that are readily available and cost-effective for the specification of new healthcare applications.
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Hybrid Technology Powers Integrated Connectors
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LoPro® 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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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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