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Claro Approval

SHAWNEE, Kan., Bayer HealthCare LLC Animal Health announces the approval of Claro™ (15.0 mg/mL florfenicol, 13.3 mg/mL terbinafine, 2.0 mg/mL mometasone furoate) Otic Solution, the first single-dose therapy proven to effectively treat susceptible strains of common pathogens found in canine otitis externa.1 The product is expected to be available for sale exclusively to veterinarians in November. Otitis externa is the second most common reason dog owners take their pet to a veterinarian2 and can be a frustrating disease for canine patients and their owners.  The condition is an inflammation of the ear canal that is often accompanied by secondary infections.  It frequently causes pain, itching, a strong odor and/or muffled hearing in […]

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Sunshine Heart Initiates Animal Study on Applicability of C-Pulse Technology in the Treatment of Pulmonary Arterial Hypertension

EDEN PRAIRIE, Minn., (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) announced today the commencement of a collaborative effort with Dr. Mark Slaughter and the University of Louisville to study the impact of the C-Pulse technology on the pulmonary circulation and right heart, specifically in the field of pulmonary hypertension and heart failure. Pulmonary arterial hypertension (PAH) is a debilitating condition characterized by progressive increases in pulmonary vascular resistance and loss of elasticity of the pulmonary artery and large vessels. Patients with PAH suffer from poor quality of life, shortness of breath and greatly reduced functional capacity leading to right ventricular dysfunction and ultimately, right heart failure. PAH afflicts approximately 200,000

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Sunshine Heart Announces FDA Approves Key Protocol Amendment for COUNTER HF(TM) US Pivotal Study for C-Pulse(R) Heart Assist System

EDEN PRAIRIE, Minn., (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (NASDAQ:SSH) is pleased to announce the US Food and Drug Administration (FDA) has approved an amendment to the stopping rule criteria for the Company’s COUNTER HF™ pivotal study for its C-Pulse Heart Assist System®. The Agency has agreed to change this protocol from “all cause” deaths to specifically, mortality associated with device, procedure or therapy. “Redefining COUNTER HF’s stoppage rule to be focused purely on C-Pulse related events is an important study protocol amendment as it greatly reduces our risk of having to pause the trial again due to unrelated C-Pulse mortality events,” commented Dave Rosa, President and Chief Executive Officer

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Datacastle RED v8 Available for Mobile Workforce Backup, Archiving and Insights

    Seattle, WA, – Datacastle®, a market leader for protecting enterprises from mobile workforce data loss and data breaches, today announced the latest version of its flagship product, Datacastle RED. Datacastle RED v8 provides enterprise customers even greater mobile workforce data protection via backup, archiving and insights. Datacastle RED v8 includes: Microsoft Enterprise Mobility Suite (EMS) Compatibility – Datacastle RED v8 integrates with Azure Active Directory for deployments and SSO, Microsoft Intune and SCCM for silent enterprise deployments, and provides mobile file access security with Azure Rights Management services compatibility Mobile Dashboard – Optimized IT experience for managing Datacastle vault administrator functions from any tablet or smartphone iOS Support – Datacastle RED

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Sunshine Heart Announces FDA Approval to Resume Enrollment in Pivotal Study

Sunshine Heart Announces FDA Approval to Resume Enrollment in COUNTER HF™ US Pivotal Study for C-Pulse® Heart Assist System EDEN PRAIRIE, Minn.,  (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) is pleased to announce that the US Food and Drug Administration (FDA) has approved the resumption of patient enrollment in its COUNTER HF US pivotal study for the C-Pulse Heart Assist System. As such, the Company has already begun the process to provide all pivotal study centers with the information required for their Investigational Review Board to approve the continuation of study enrollment. “Resuming enrollment in COUNTER HF has been our top priority and was accomplished within the timelines originally announced.

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Datacastle Provides a Year of FREE Endpoint Backup and Data Protection Licenses for Microsoft Azure Customers

Seattle, WA,  – Datacastle, a market leader in enterprise endpoint backup and data protection, announced today a promotion of its Datacastle RED service, for qualifying Azure customers. Datacastle RED helps protect enterprises from ransomware extortion, data loss and data breach through simplified and scalable endpoint backup and data protection, in the cloud. Datacastle’ s hybrid services running on Azure, enable enterprises to rapidly experience LAN-speed performance with the assurance of offsite, cloud-based recoverability and mobile access. During the promotion, qualifying Azure customers are able to further the protections of their laptops, high-end tablets, and desktop computers from ransomware extortion, data loss, and data breaches, at no additional Datacastle license cost,

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UBI – Siemens announces full launch of Award Winning Xprecia Stride™ Coagulation Analyzer

Siemens Healthcare Diagnostics, Inc. (“Siemens”) today announced the full commercial launch of the Xprecia Stride™  Coagulation Analyzer following successful completion of its limited European release. The system will now be marketed through Siemens’ extensive sales and distribution network in a growing number of markets, currently excluding the U.S. (which will require FDA 510(k) clearance). In addition, Siemens has today announced that the Xprecia Stride™  Coagulation Analyzer has been awarded the internationally respected Red Dot Award for Product Design for 2015. The Red Dot Product Design Competition started in Germany in 1954 and its award, the ‘Red Dot,’ is an internationally recognised quality seal. See www.red-dot.org for further details on the

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Datacastle Enters into OEM Agreement with 21Vianet for Cloud-based endpoint Data Protection in China

Seattle, WA,  – Datacastle, a market leader in enterprise endpoint backup and data protection, today announced it has signed a multi-year agreement with 21Vianet (Nasdaq:VNET) to allow 21Vianet to resell the Datacastle RED solution for laptop, desktop and tablet data protection. The new 21Vianet offering will be sold under the 21Vianet brand and will be offered as a Microsoft Azure, cloud-based solution in China. Datacastle protects enterprises from ransomware extortion, data loss and data breach with simplified and scalable endpoint backup and data protection. Datacastle RED’s hybrid cloud deployment option with Microsoft Azure enables enterprises to rapidly experience LAN-speed performance with the assurance of offsite, cloud-based recoverability and mobile access.

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Sunshine Heart Receives FDA Approval for Interim Analysis of US Pivotal Trial

Sunshine Heart Receives FDA Approval for Interim Analysis of U.S. Pivotal Trial of C-Pulse® Heart Assist System EDEN PRAIRIE, Minn.,  (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) today announced it has received unconditional approval from the FDA to conduct an interim analysis of COUNTER HF, the Company’s U.S. pivotal study. The COUNTER HF study is a prospective, randomized, multi-center, controlled study that evaluates the safety and efficacy of the C-Pulse system for the treatment of NYHA Class III and ambulatory Class IV heart failure. Integral to the COUNTER HF study is the assessment of C-Pulse’s unique balloon counterpulsation treatment designed to improve heart function and reduce re-hospitalizations due to worsening heart failure.

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Datacastle Honored as Coolest Cloud Computing Vendor by CRN

Seattle, WA,  – Datacastle, a market leader in enterprise endpoint backup and data protection, today announced it has earned recognition on The Channel Company’s CRN 100 Coolest Cloud Computing Vendors of 2015. This annual list recognizes some of the most innovative cloud companies supporting the IT channel today. The 100 Coolest Cloud Computing Vendors honor is presented to companies based on their approach to creating innovative products, services or partner programs that have helped channel partners transform into true solution providers, ultimately helping customers take advantage of the ease of use, flexibility, scalability and savings that cloud computing offers. Datacastle RED is recognized for its hybrid cloud, enterprise class endpoint

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Piedmont Animal Health Achieves Second FDA Approval In Less Than 18 Months

Robust pipeline places company in position to be among top seven US companion animal veterinary pharmaceutical companies by 2020 GREENSBORO, N.C., –Piedmont Animal Health announces its second approval from the Food and Drug Administration for companion animals, new advantusTM (imidacloprid) soft chew, an oral flavored chewable flea medication for dogs.i The new animal drug application (NADA) is formulated in Piedmont’s patented soft chew invention, offering convenient, palatable dosing. The approval represents the second FDA approval for Piedmont and its first NADA approval. In June 2013, Piedmont announced the approval of quellinTM (carprofen) soft chews, an abbreviated new animal drug application (ANADA).ii Rapid Product Development “From start to finish, this product

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UBI – Launch of Siemens Xprecia Stride™ Coagulation Analyzer for the point of care

Universal Biosensors, Inc. (ASX: UBI) is pleased to announce that Siemens Healthcare Diagnostics Inc. (“Siemens”) has initiated the European limited release of the Xprecia Stride™ Coagulation Analyzer, its first point-of-care coagulation testing product. The Xprecia Stride™ Coagulation Analyzer is a PT-INR testing system that incorporates UBI’s unique electrochemical sensing technology which offers high performance and ease-of-use in an affordable, handheld format. The product launch has triggered a milestone payment of US$1 million from Siemens to Universal Biosensors. Universal Biosensors CEO Paul Wright said: “This is an important milestone for both Universal Biosensors and Siemens. We have been collaborating on the development of this product for more than three years and

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Blood coagulation testing system approved for the European market

9 December 2014 Universal Biosensors, Inc. (ASX: UBI) is pleased to announce that Siemens Healthcare Diagnostics Inc. (“Siemens”) has received CE Mark approval for the Xprecia Stride™ Coagulation Analyzer, the first point-of-care coagulation analyzer developed in collaboration with Universal Biosensors. The Xprecia Stride™ Coagulation Analyzer is a prothrombin time (PT-INR) testing system used to monitor the application of the anti-coagulant therapy, Warfarin. Universal Biosensors will exclusively manufacture PT-INR strips for Siemens at the Company’s existing plant in Rowville, Victoria. The CE marking follows the receipt of two commercial orders from Siemens for the production and supply of PT-INR test strips by Universal Biosensors, and is the final step prior to

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Sunshine Heart Provides Update on OPTIONS HF EU Post-Market Study

Austrian Site Achieves First Implant EDEN PRAIRIE, Minn., Dec. 1, 2014 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) announced today that the Company’s initial Austrian site for the OPTIONS-HF study has implanted its first patient with the C-Pulse System for moderate to severe heart failure. Prof. Dr. Herwig Antretter of the University of Innsbruck performed the operation, which took place on November 11th, 2014. A 92 minute surgical implantation procedure was successfully completed and the patient was discharged from the hospital 7 days post-surgery. This milestone marks the eleventh implantation of the C-Pulse System across fourteen activated EU centers participating in the OPTIONS HF post-market surveillance clinical study. “The C-pulse

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Piedmont Prepares For Veterinary Companion Animal Product Launches

GREENSBORO, N.C.,  – Piedmont Pharmaceuticals, LLC, an innovative pharmaceutical company focused on veterinary market pharmaceuticals, today announced its hiring of Mr. Stan Cruitt as Vice President of Marketing Services. “We couldn’t be more pleased to have Stan join our team. His longstanding record of animal health pharmaceuticals launch success represents perfect timing as we at Piedmont are beginning to prepare for significant product launches,” said Roland Johnson, founder, CEO and Board member of Piedmont Pharmaceuticals. “His record on market and product evaluation, product positioning and communications/marketing strategies stands against the very best in the industry. Stan was honored as one of the top marketers in the US by Advertising Age

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Datacastle Achieves Microsoft Gold Cloud Competency

Datacastle demonstrates best-in-class capability and market leadership through demonstrated technology success and customer commitment. Seattle, WA — Datacastle®, a market leader in enterprise endpoint backup and data protection, today announced it has attained a Gold Cloud Platform Competency, demonstrating a “best-in-class” ability and commitment to meet Microsoft Corp. customers’ evolving needs in today’s dynamic business environment and distinguishing itself within the top 1 percent of Microsoft’s partner ecosystem. To earn a Microsoft Gold Competency, partners must successfully complete exams (resulting in Microsoft Certified Professionals) to prove their level of technology expertise, and then designate these certified professionals uniquely to one Microsoft competency, ensuring a certain level of staffing capacity. They also

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Datacastle Announces Datacastle RED v7

Datacastle brings eDiscovery support, Legal Hold, and rapid hybrid cloud deployment enhancements to enterprise endpoint data protection Press Release: Datacastle – Wed, 17 Sep, 2014 9:45 AM EDT SEATTLE, Sept. 17, 2014 /PRNewswire/ — Datacastle®, a market leader for protecting enterprises from endpoint data loss and data breaches, today announced the latest version of its flagship product, Datacastle RED. Datacastle RED v7 provides enterprise customers even greater hybrid cloud deployment options with data backup and replication on Microsoft Azure, as well as support for eDiscovery and Legal Hold processes. Datacastle RED v7 includes: Rapid Deployment Support – enhanced hybrid cloud deployment on Microsoft Azure, enterprise deployment integrations with Active Directory, LDAP, silent installation, and

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ThreatMetrix to Provide Location Detecting Solution to Businesses in Accordance with Office of Foreign Assets Control (OFAC) Regulations

September 3, 2014 The ThreatMetrix TrustDefender™ Cybercrime Protection Platform Will Help Institutions Meet the Treasury Office’s International Business Regulations San Jose, CA – September 3, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced it will work with businesses to ensure they are compliant with the Office of Foreign Assets Control (OFAC) regulations that prohibit business transactions with embargoed or restricted countries or entities. To be compliant with OFAC regulations, businesses must know the true location of their business clientele and customers, which becomes increasingly challenging for businesses such as banks, as customers frequently disguise their locations in an effort to maintain privacy and

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ThreatMetrix Selected as One of CIOReview100’s Most Promising Technology Companies

August 19, 2014  Context-Based Security and Advanced Fraud Prevention Provider Recognized for Powerful, Flexible and Cost-Effective Security Solutions San Jose, CA – August 19, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced it has been recognized by CIOReview as one of the “100 Most Promising Technology Companies in the U.S.” CIOReview100 is an annual list selected by a panel comprised of top CEOs, CIOs and industry analysts including the CIOReview editorial board to honor the top 100 technology companies in the U.S. This year, the list honored the most promising technology companies for their use of powerful next generation technologies such as cloud,

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Sunshine Heart’s C-Pulse(R) System Allows Father to Attend Daughter’s Wedding

EDEN PRAIRIE, Minn., Aug. 19, 2014 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) today announced that the current condition of a heart failure patient implanted with the C-Pulse® System improved after six weeks of treatment, allowing him to attend his daughter’s wedding. The patient, Ross Swift, a 54 year-old grandfather from Devon, U.K., received C-Pulse at Harefield Hospital in London and is participating in the OPTIONS HF study, a post-market surveillance study being conducted in countries in Western Europe. C-Pulse system received the CE Mark in 2012. The story was reported in an article published today in The Daily Mail, titled, Me and My Operation: Pump that squeezes your arteries

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Heart failure treatment gives man ‘a life again’

August 8, 2014 Ross Swift said his life had improved, but he remains on the organ transplant list A Devon man fitted with a new device aimed at supporting a failing heart, says it means he has “a life again”. Ross Swift, 54, from Ivybridge, is believed to be the first UK patient to receive the Sunshine Heart implant, which helps reduce the organ’s pumping workload. Mr Swift said the device meant he had was able to walk his daughter down the aisle at her wedding this month. One expert said the device added a “tremendous amount of quality of life”. The implant, called the C-Pulse, involves a cuff or balloon which

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ThreatMetrix Extends Mobile and Web Context-Based Security and Fraud Prevention Innovation with Patent

July 29, 2014  Latest Patent Will Continue to Build Trust on the Internet Using Global Intelligence San Jose, CA – July 29, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced the United States Patent and Trademark Office has granted the company a new patent for its ability to accurately differentiate between trusted customers and cybercriminals across mobile and web interactions. The new patent is U.S. Patent 8,782,783: “Method and System for Tracking Machines on a Network Using Fuzzy GUID (Globaly Unique Identifier) Technology.” This is a continuation of a previous patent that provides the cornerstone technology for ThreatMetrix industry leading cookieless device identification

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Piedmont Pharmaceuticals Announces New Chairman of the Board

Piedmont Pharmaceuticals Announces New Chairman of the Board GREENSBORO, N.C., (July 15, 2014) – Piedmont Pharmaceuticals, LLC, an innovative specialty pharmaceutical company focused on animal health and human therapeutics, today announced its Board of Directors and shareholders have elected industry veteran Dennis Steadman chairman and member of the Board of Directors effective immediately. “There is no better person than Dennis Steadman to help Piedmont Pharmaceuticals as we transition the company to a fully integrated research and development, marketing and sales pet health business,” said Roland Johnson, founder, CEO and member of the Board of Directors of Piedmont Pharmaceuticals, LLC. “His strategic vision, combined with operational experience ranging from capital funding

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ThreatMetrix Named One of the Hottest Companies in Silicon Valley by Lead411

July 8, 2014 Context-Based Security and Advanced Fraud Prevention Provider Recognized for Tremendous Annual Growth and Recent Funding San Jose, CA – July 8, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced it has been recognized as one of the 2014 “Hottest Companies in Silicon Valley” by Lead 411. Lead411’s “Hottest Companies in Silicon Valley” list recognizes privately held companies in the software, wireless, Internet, hardware and media industries within Silicon Valley. Each company must have either doubled its revenue over the past two years or received more than $5 million in funding in the past two years. This list originally started with over

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Sunshine Heart Appoints Brian Brown as Senior Vice President of Operations and Technology

Sunshine Heart Appoints Brian Brown as Senior Vice President of Operations and Technology EDEN PRAIRIE, Minn., June 16, 2014 (GLOBE NEWSWIRE) — Sunshine Heart, Inc. (Nasdaq:SSH) today announced the appointment of Brian Brown to the position of Senior Vice President of Operations and Technology. In this capacity, Mr. Brown will manage the Company’s R & D program for its flagship C-Pulse® Heart Assist System, a medical device addressing Class III and ambulatory Class IV heart failure. Additionally, Mr. Brown will be responsible for operations inclusive of internal and contracted manufacturing. Mr. Brown comes to Sunshine Heart after serving as R & D, Vice President Cardiovascular at Boston Scientific for the

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Nokia buys compact radio systems expert Mesaplexx

Espoo, Finland – Nokia confirms that it has recently completed the acquisition of the Australian company Mesaplexx Pty Ltd in order to boost its radio capabilities in the Networks business. Mesaplexx has unique know-how in developing compact, high performance radio frequency (RF) filter technology for the mobile industry. Nokia is continually improving its radio systems whilst making them smaller, lighter and more efficient. The Nokia Flexi family of radio access base stations offers cutting-edge solutions that balance energy efficiency, power output and form factor. Adding the very advanced Mesaplexx technology can enhance them further, potentially reducing small cells form factor by 30% or more. Every base station needs RF filters,

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ThreatMetrix Wins Judges Choice for Best Overall Fraud/Security Solution at 2014 CNP Awards

TrustDefender™ Cybercrime Protection Platform Recognized for Offering Unified Intelligence with Integrated Cybercrime Protection Platform San Jose, CA – May 28, 2014 – ThreatMetrix®, the fastest-growing provider of context-based security and advanced fraud prevention solutions, today announced that the TrustDefender™ Cybercrime Protection Platform won the Judges Choice for Best Overall Fraud/Security Solution at the 2014 CardNotPresent.com (CNP) Awards. The CNP Award for Best Overall Fraud/Security Solution recognizes the provider that most efficiently reduced costs related to fraud in card-not-present transactions by identifying as much potential fraudulent activity as possible while enabling merchants to accept as many transactions as possible. The awards were announced during the CNP Expo, held May 19-22 in Orlando. “Significant growth in

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Rio Tinto to deploy 6.7MW solar PV + storage at off-grid mine

By Giles Parkinson on 22 May 2014 A ground-breaking, $23.4 million project to cut out daytime diesel consumption at Rio Tinto bauxite mine at Weipa could unlock billions of dollars of similar investments in the mining industry – which is weighed down by soaring energy costs. Mining giant Rio Tinto is to host a $23.4 million solar PV plus storage facility at its Weipa bauxite mine, that is the first of its type and scale in the world and could unleash billions of dollars of similar investment. Rio Tinto Alcan – with the help of the Australian Renewable Energy Agency – is to install a 1.7MW solar PV array at its Weipa

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US solar giant and Rio Tinto agree on Australian-first solar project

KERRIE SINCLAIR  THE COURIER-MAIL  MAY 22, 2014 12:00AM ONE of the world’s biggest solar panel makers, US-based First Solar, is set to next month start building a $23.4 million solar power plant at Weipa after sealing a power purchase deal with miner Rio Tinto as well as federal funding. It is the first time in Australia that a mining company has adopted renewable energy to power a mining operation. Rio Tinto said the 6.7 megawatt solar photovoltaic solar farm would provide power to the Rio Tinto Alcan Weipa bauxite mine, processing facilities as well as the township on the Western Cape York Peninsula. “We expect the use of solar power will

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