|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.
"At ROHA we develop an app called Catcha. It was developed after we spent a year meeting with, talking to, interacting with senior citizens watching them use their smartphones and talking to them about how they use their smartphones so we could get to know their smartphone behavior," explained Dave Woods, Chief Innovation Officer at ROHA, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 11:15 AM EST Reads: 339
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Dec. 6, 2016 11:00 AM EST Reads: 534
SYS-CON Events has announced today that Roger Strukhoff has been named conference chair of Cloud Expo and @ThingsExpo 2017 New York. The 20th Cloud Expo and 7th @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "The Internet of Things brings trillions of dollars of opportunity to developers and enterprise IT, no matter how you measure it," stated Roger Strukhoff. "More importantly, it leverages the power of devices and the Internet to enable us all to im...
Dec. 6, 2016 10:59 AM EST
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU's GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes. In...
Dec. 6, 2016 10:30 AM EST Reads: 1,152
"Venafi has a platform that allows you to manage, centralize and automate the complete life cycle of keys and certificates within the organization," explained Gina Osmond, Sr. Field Marketing Manager at Venafi, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 10:30 AM EST Reads: 952
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 10:15 AM EST Reads: 528
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Dec. 6, 2016 09:15 AM EST Reads: 2,141
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Dec. 6, 2016 09:00 AM EST Reads: 5,810
"Qosmos has launched L7Viewer, a network traffic analysis tool, so it analyzes all the traffic between the virtual machine and the data center and the virtual machine and the external world," stated Sebastien Synold, Product Line Manager at Qosmos, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 09:00 AM EST Reads: 707
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 6, 2016 09:00 AM EST Reads: 3,965
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Dec. 6, 2016 08:45 AM EST Reads: 7,125
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
Dec. 6, 2016 08:30 AM EST Reads: 1,336
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 6, 2016 08:30 AM EST Reads: 880
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Dec. 6, 2016 08:15 AM EST Reads: 1,672
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Phil Hombledal, Solution Architect at CollabNet, discussed how customers are able to achieve a level of transparency that e...
Dec. 6, 2016 08:15 AM EST Reads: 1,063