|By Marketwired .||
|April 30, 2014 09:18 AM EDT||
LOS ANGELES, CA -- (Marketwired) -- 04/30/14 -- Decision Diagnostics Corp. (OTCQB: DECN), and its subsidiary Pharma Tech Solutions, the FDA registered manufacturer and owner/operator for the popular GenStrip, a medical device specifically designed to work with the Johnson & Johnson's LifeScan Ultra family of glucose testing meters, today will comment on the April 29, 2014 FDA issued safety communication about the quality systems issues at Shasta Technologies LLC, the former owner/operator of GenStrip. Shasta is no longer involved with GenStrip.
The company believes that the FDA communication is accurate in its criticism of the repeated failures of Shasta to comply with minimum standards of quality procedure and regulatory compliance. Their continued noncompliance was the motivating factor behind the March 20, 2014 acquisition of the GenStrip Intellectual Property and the 510(k). The existing product supplied by Shasta performed safely and effectively, met or exceeded its own 510(k) described standards, and there have been no reported incidents regarding patient safety or health and it is now under the regulatory control of the company's PharmaTech subsidiary and is fully compliant with the mandated quality procedure policies and documentation.
Keith Berman, Principal Executive Officer of DECN, commented, "We agree with the FDA that Shasta was incapable of properly overseeing GenStrip manufacturing. That is why our subsidiary, PharmaTech Solutions, has acquired GenStrip, its marks, and the 510(k). By virtue of our acquisition, we have assumed all manufacturing and quality systems responsibilities. Shasta's role in GenStrip has ended. We are pleased to announce that the Genstrip product has now been re-branded as, 'PharmaTech GenStrip 50.' GenStrip 50 will be enclosed in redesigned packaging and will shortly be available on our customers' shelves. More importantly, GenStrip 50 will continue to be made in the USA by the same leading diagnostic strip contract manufacturer."
Mr. Berman concluded, "Despite the fact that the issued FDA warning was directed solely to Shasta Technologies and is wholly their responsibility, as the acquirers of the technology and Intellectual Property, Decision Diagnostics and its subsidiary PharmaTech Solutions has committed to replace every box of GenStrip manufactured during Shasta's tenure as manufacturer and owner operator. This guarantee is regardless of where the patient may have purchased the product, or how any Genstrip seller or distributor may have acquired the product, its replacement will be honored. Any replaced product returned to PharmaTech will be destroyed."
Forward Looking Statements:
This release contains forward-looking statements about our business or financial condition that reflect our assumptions and beliefs based on information currently available. We can give no assurance that the expectations indicated by such forward-looking statements will be realized. There may be other risks and circumstances that we are unable to predict. When used in this release, words such as "believes," "expects," "forecasts," "intends," "projects," "plans," "anticipates," "estimates" and similar expressions are intended to identify forward-looking statements, although there may be certain statements not accompanied by such expressions.
GenStrip 50 test strips are a product of PharmaTech Solutions, Inc. and are not manufactured, distributed, endorsed, or approved by nor associated with LifeScan®, Inc. a Johnson & Johnson® Company, manufacturers and distributors of the OneTouch® Ultra® Family of Meters and OneTouch® Ultra® test strips.
Decision Diagnostics Corp.
SYS-CON Events announced today that BMC will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BMC delivers software solutions that help IT transform digital enterprises for the ultimate competitive business advantage. BMC has worked with thousands of leading companies to create and deliver powerful IT management services. From mainframe to cloud to mobile, BMC pairs high-speed digital innovation with robust...
May. 27, 2015 05:30 PM EDT Reads: 632
As cloud gives an opportunity to businesses to buy services externally – how is cloud impacting your customers? In his General Session at 15th Cloud Expo, Fabio Gori, Director of Worldwide Cloud Marketing at Cisco, provided answers to big questions: Do you see hybrid cloud as where the world is going? What benefits does it bring? And how does Cisco connect all of these clouds? He also discussed Intercloud and Cisco’s investment on it.
May. 27, 2015 05:00 PM EDT Reads: 5,814
Over the years, a variety of methodologies have emerged in order to overcome the challenges related to project constraints. The successful use of each methodology seems highly context-dependent. However, communication seems to be the common denominator of the many challenges that project management methodologies intend to resolve. In this respect, Information and Communication Technologies (ICTs) can be viewed as powerful tools for managing projects. Few research papers have focused on the way...
May. 27, 2015 05:00 PM EDT Reads: 1,718
As the world moves from DevOps to NoOps, application deployment to the cloud ought to become a lot simpler. However, applications have been architected with a much tighter coupling than it needs to be which makes deployment in different environments and migration between them harder. The microservices architecture, which is the basis of many new age distributed systems such as OpenStack, Netflix and so on is at the heart of CloudFoundry – a complete developer-oriented Platform as a Service (PaaS...
May. 27, 2015 05:00 PM EDT Reads: 1,601
Containers Expo Blog covers the world of containers, as this lightweight alternative to virtual machines enables developers to work with identical dev environments and stacks. Containers Expo Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Bookmark Containers Expo Blog ▸ Here Follow new article posts on Twitter at @ContainersExpo
May. 27, 2015 04:00 PM EDT Reads: 999
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover ...
May. 27, 2015 04:00 PM EDT Reads: 6,392
In their general session at 16th Cloud Expo, Michael Piccininni, Global Account Manager – Cloud SP at EMC Corporation, and Mike Dietze, Regional Director at Windstream Hosted Solutions, will review next generation cloud services, including the Windstream-EMC Tier Storage solutions, and discuss how to increase efficiencies, improve service delivery and enhance corporate cloud solution development. Speaker Bios Michael Piccininni is Global Account Manager – Cloud SP at EMC Corporation. He has b...
May. 27, 2015 03:45 PM EDT Reads: 1,121
SYS-CON Events announced today that O'Reilly Media has been named “Media Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York City, NY. O'Reilly Media spreads the knowledge of innovators through its books, online services, magazines, and conferences. Since 1978, O'Reilly Media has been a chronicler and catalyst of cutting-edge development, homing in on the technology trends that really matter and spurring their adoption...
May. 27, 2015 03:37 PM EDT Reads: 327
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
May. 27, 2015 03:30 PM EDT Reads: 1,135
The OpenStack cloud operating system includes Trove, a database abstraction layer. Rather than applications connecting directly to a specific type of database, they connect to Trove, which in turn connects to one or more specific databases. One target database is Postgres Plus Cloud Database, which includes its own RESTful API. Trove was originally developed around MySQL, whose interfaces are significantly less complicated than those of the Postgres cloud database. In his session at 16th Cloud...
May. 27, 2015 03:15 PM EDT Reads: 1,122
The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete at launch. DevOps may be disruptive, but it is essential. The DevOps Summit at Cloud Expo – to be held June 3-5, 2015, at the Javits Center in New York City – will expand the DevOps community, enable a wide...
May. 27, 2015 03:00 PM EDT Reads: 1,894
EMC Corporation on Tuesday announced it has entered into a definitive agreement to acquire privately held Virtustream. When the transaction closes, Virtustream will form EMC’s new managed cloud services business. The acquisition represents a transformational element of EMC’s strategy to help customers move all applications to cloud-based IT environments. With the addition of Virtustream, EMC completes the industry’s most comprehensive hybrid cloud portfolio to support all applications, all workl...
May. 27, 2015 03:00 PM EDT Reads: 769
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, focused on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud platfo...
May. 27, 2015 03:00 PM EDT Reads: 5,358
SYS-CON Events announced today that MetraTech, now part of Ericsson, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Ericsson is the driving force behind the Networked Society- a world leader in communications infrastructure, software and services. Some 40% of the world’s mobile traffic runs through networks Ericsson has supplied, serving more than 2.5 billion subscribers.
May. 27, 2015 02:00 PM EDT Reads: 1,274
How does one bridge the gap between traditional enterprise storage infrastructures and the private, hybrid, and public cloud? In his session at 15th Cloud Expo, Dan Pollack, Chief Architect of Storage Operations at AOL Inc., examed the workload differences and required changes to reuse existing knowledge and components when building and using a cloud infrastructure. He also looked into the operational considerations, tool requirements, and behavioral changes required for private cloud storage s...
May. 27, 2015 02:00 PM EDT Reads: 2,672