Medical Technology: Vol 1, Issue 3

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RainDance Technologies Announces Shipment of RDT 1000, Sequence Enrichment Solution to TGen Researchers		Genzyme Receives European Approval of Renvela for Patients with Chronic Kidney Disease
Lexington MA – RainDance Technologies, Inc., announced the shipment of an RDT 1000 and Sequence Enrichment Solution to the Translational Genomics Research Institute (TGen). RainDance is a provider of innovative microdroplet-based solutions for human health and disease research. TGen, a nonprofit biomedical research institute based in Phoenix, Arizona, focuses on the translation of laboratory discoveries into personalized medicine, developing earlier diagnostics and better treatments for patients with many forms of cancer, neurological and cardiovascular diseases, and infectious diseases. Dr. David Duggan, an Investigator in TGen's Genetic Basis of Human Disease Division, said one of the initial applications of the RainDance solution would focus on resequencing regions of the human genome identified as part of genome-wide association studies.		Cambridge MA - Genzyme Corporation announced that the European Commission has approved Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels ≥ 1.78 mmol/L (5.5 mg/dL), and covers both the tablet and powder formulations. "With this marketing authorization, Renvela is the first phosphate binder for patients not on dialysis approved through the centralized procedure in Europe," said Dan Regan, Senior Vice President and General Manager of Genzyme's renal business. "This is an important step toward improved patient care, and we are pleased that CKD patients in Europe will now have access to this proven therapy."
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CareMedic Launches Patient Access Management Solution in Collaboration with Cleveland Clinic		Next Generation Swager from Machine Solutions Inc. Reduces Production Costs with Automated Batch Processing
St Petersburg FL - CareMedic Systems, Inc., a leader in proactive financial management for hospitals and providers, today announced it has launched the Patient Access Management solution to help healthcare organizations realize the positive benefits of a front-end-focused revenue cycle operation. The solution extends existing CareMedic solutions with new registration guidance processes, ensuring that all information (demographics, medical necessity, insurance, co-pays, deductibles, and payments) is captured and verified during the patient intake process with precise accuracy, producing greater clean claim rates, resulting in fewer denials or payment delays. It also incorporates a new financial clearance software solution developed by the Cleveland Clinic to further address the challenges associated with self pay, charity care, and consumer healthcare impact.		Flagstaff AZ - Machine Solutions Inc. (MSI) announces the launch of its next generation SW575S Automated Marker Band Swaging Equipment intended to reduce production costs with automated batch processing. This machine automatically positions and swages marker bands within tight manufacturing tolerances. Intended for high volume PTCA product manufacturing, the pick and place feeding option allows for continuous, automated processing. "MSI's mission has always been to meet customer needs and in this economy increasing productivity is a must. Now with the new SW575S a single operator can monitor multiple machines which saves time and money on the manufacturing floor," says Product Manager Melissa Lachowitzer. "Some of our early adopters of the technology have found that the tight tolerances the machine holds on band position can reduce their post inspection time." The profile driven SW575S includes an integrated PLC control system with touch screen interface for easy process development and quick product changeover.
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Series 660/668 Pumps from Thomas Solve Medical Device, Environmental Challenges		Carl Zeiss Meditec Receives FDA Clearance for Cirrus HD-OCT Software Version 4.0
Sheboygan WI -- Series 660/680 WOB-L Piston pumps from Thomas incorporate a package of features to provide clean air-flow, long life, excellent efficiency, low noise and low vibration. These pumps are well-suited to a variety of medical and environmental applications, including oxygen concentrators, blood analyzers, dental carts and ozone generators. The pumps' oil-less pistons and cylinders, plus efficient intake filters, ensure a non-contaminated air flow. Stainless steel valves, high-performance piston seals, hard-coated aluminum cylinders and permanently lubricated bearings offer long-life performance. Wetted aluminum parts are treated for corrosion protection. The pumps' single-phase AC motors are of ultra reliable permanent split capacitor design, which eliminates the need for a starting switch. Series 660/680 pumps provide up to 28.5 in. Hg (-965 mbar) of vacuum, or 45 psi (3.1 bar) of pressure. Maximum flow is rated at 2.37 CFM (67.1 l/min).		DUBLIN, Calif. --(BUSINESS WIRE)-- A new suite of optical coherence tomography (OCT) software applications for the Cirrus HD-OCT has been cleared by the U.S. Food and Drug Administration (FDA) for commercial distribution. The Cirrus HD-OCT 4.0 with Retinal Nerve Fiber Layer and Macular Normative Databases is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures. "Throughout our 15 year history of OCT innovation, we have seen its utility evolve from imaging of the retina to now offering both posterior and anterior capabilities," said Michael Kaschke, PhD, President and Chief Executive Officer of Carl Zeiss Meditec. "The Cirrus HD-OCT 4.0 incorporates the latest applications to provide eye care professionals with the tools and analyses needed to manage complex eye conditions throughout a patient's lifetime."
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Series 300P Indicating Snap Gages from Mahr Federal Offer Speed, Accuracy, Flexibility and Economy		Applied Engineering Plastics Now Have USP Class VI Colored PEEK Available
PROVIDENCE, RI – Mahr Federal's Series 300P Indicating Snap Gages are an excellent choice for highly accurate and reliable measurement results on cylindrical parts with narrow tolerance ranges. The gages are available in a variety of sizes with measuring capacity increasing in 1" (25 mm) increments up to 9" (229 mm). Series 300P Snap Gages can be configured with a number of different indicators and all are fully adjustable with positive position locking at any point within the gaging range. "Snap gages are one of the easiest, fastest, most accurate and economical ways of making OD measurements a shop can employ," said George Schuetz, Director of Precision Gages for Mahr Federal. "They are very versatile. They can be hand held to measure parts in place, or mounted on bench stands. They can be set up with different indicators for any number of readout configurations. Different anvil styles adapt to a host of measurement conditions. And parts literally 'snap' into place, which assures good part alignment, and along with positive position locking, virtually eliminates operator influence on the measurement."		Earth City MO - Applied Engineering Plastics, Inc., specialists in the precision machining of high performance plastics for medical, dental, analytical testing and pharmaceutical applications, in partnership with Ensinger are announcing the availability of USP Class VI certified colored PEEK. PEEK is an ultra-high performance biocompatible thermoplastic valued for it's chemical resistance, mechanical strength, dimensional stability and extreme resistance to hydrolysis – even at high temperatures. The addition of 6 FDA compatible colors makes TECAPEEK MT an ideal choice for sizing trials, instrumentation, and part differentiation preventing cross contamination on pharmaceutical processing lines.
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Medtronic Receives FDA Approval for BRYAN Cervical Disc System		GE Healthcare Installs Next Evolution in Nuclear Cardiology Scanners Globally
MEMPHIS, Tenn. –– Medtronic, Inc. announced that it received U.S. Food and Drug Administration (FDA) approval to market the BRYAN Cervical Disc System for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy). In July 2007, Medtronic's PRESTIGE Cervical Disc was the first artificial cervical disc to be approved by the FDA. With the BRYAN Disc and the PRESTIGE Disc, Medtronic now offers a diverse portfolio of artificial cervical discs that address varying philosophies among spine surgeons about optimal implant materials, fixation methods, surgical techniques, and other unique design features. The BRYAN Cervical Disc is a titanium-polyurethane prosthetic device that is inserted between the vertebrae to replace the natural spinal disc. The BRYAN Cervical Disc is designed to maintain range of motion in the neck which the potential alternative anterior cervical discectomy and fusion (ACDF) does not.		United Kingdom - GE Healthcare announced today the first four installations of its new cadmium zinc telluride (CZT) based Discovery NM 530c nuclear cardiology camera featuring Alcyone Technology. This revolutionary imaging system has been installed at Mt. Sinai Medical Center in New York City, United States, Ottawa Heart Institute in Ottawa, Canada, University Hospital in Zurich, Switzerland and Gabriele Monasterio Foundation, CNR, in Pisa, Italy. "The Discovery NM 530c camera will have a very positive impact on Nuclear Cardiology practice," said Dr. Milena Henzlova, Director of Nuclear Cardiology at Mt. Sinai Hospital. "There is huge potential for improved efficiency, image quality and new applications. After 40 years of Anger camera technology, it is exciting to be part of a new chapter in Nuclear Cardiology."
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St. Jude Medical Announces Initial Implant of First-to-Market Connector System in the U.S.		Premier Healthcare Alliance Enhances Solution to Help Hospitals Control Costs Through Supply Cost Benchmarking, Comparative Analysis
ST. PAUL, Minn., (BUSINESS WIRE) -- St. Jude Medical, Inc. today announced the first implant of its Current(R) Plus implantable cardioverter defibrillator (ICD), featuring the SJ4 connector system. The St. Jude Medical SJ4 connector reduces the number of connections between the device and the wires (defibrillation leads) that send electrical impulses to the heart, which is intended to enable a streamlined implant procedure. The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device). Previous defibrillator lead designs required three separate connections and four set screws.		CHARLOTTE, N.C. – To help its member hospitals control supply chain costs while improving quality, the Premier healthcare alliance has released an enhanced version of SupplyFocus, the healthcare industry's leading supply cost benchmarking and comparative analysis tool. The latest enhancement to SupplyFocus, used by more than 700 hospitals and healthcare systems, allows users to more quickly and easily identify pharmaceutical cost-saving opportunities. Pharmaceutical spend currently makes up 15 percent to 20 percent of a typical community hospital's total operating cost. Said Premier Purchasing Partners President Mike Alkire, "Due to the current economic conditions, healthcare facilities are increasingly focused on controlling costs that fall directly toward the bottom line…"
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Gentel Biosciences Announces Invitation to Collaborate in Clinical Research and Development Consortium for Diseases of Pregnancy		dbMotion and CAP STS Team to Realize Vision of Advanced Interoperability
MADISON, WI - Gentel Biosciences, an acknowledged leader in protein microarray technology, announced it has been invited to join a collaborative Clinical Research and Development consortium using novel technologies developed by the company to gain insight into major diseases of pregnancy.Gentel will participate in the development, validation and deliver a quantitative multiplex protein assay to the SCOPE Study centers operating in New Zealand, Australia, the UK and the US. SCOPE Study researchers may use the assay to discover and measure biomarkers to predict late stage pregnancy complications like preeclampsia. Every year more than $41 billion dollars is spent on treating these late stage diseases of pregnancy.		Hod HaSharon, Israel and Deerfield, Ill. - dbMotion, a provider of health interoperability and intelligence solutions, and SNOMED Terminology Solutions (STS), a division of the College of American Pathologists (CAP), and a leading organization in offering customized, best-practice terminology implementation and education services, today announced a partnership aimed at delivering a solution that enables their clients to reach the highest levels of interoperability and raises the industry's bar for advanced interoperability. This solution aims to define a semantic health information exchange (HIE) ontology based on SNOMED Clinical Terms® (SNOMED CT®) for clinical vocabularies that is essential for achieving semantic interoperability. "This joint development enhances the ability of the dbMotion platform's applications and services to make use of the 'true' meaning of interoperable shared information that in turn empowers healthcare teams and enhances clinical workflows," said Ziv Ofek, founder and chief technology officer of dbMotion.
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Roche: "We Innovate Healthcare"

For over 110 years now, Roche has been a pioneer in the discovery, development, production and marketing of novel healthcare solutions. Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system.

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