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Home / News / StatSure Diagnostic Systems Selects Clinivation Enterprise Solution for Global Market Clearance Management
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StatSure Diagnostic Systems Selects Clinivation Enterprise Solution for Global Market Clearance Management

Emerging leader in rapid immunoassay tests for infectious diseases selects Global 2.0 to manage its medical devices approvals and submissions worldwide.

Framingham, MA, January 12, 2006 – clinivation, Inc. announced today that StatSure Diagnostic Systems, Inc. (NASDAQ NM: SVAD) has selected clinivation Global™ 2.0 software.

“StatSure Diagnostics is an emerging leader in next-generation diagnostic testing applications for important infectious diseases and other medical conditions, and we are pleased they have selected clinivation Global 2.0 to help them build and track their medical device approvals and submissions worldwide,” said Joseph Kozikowski, M.D., clinivation’s Chief Executive Officer.

Clinivation Global 2.0 software enables medical device companies to sell more products to more countries faster and easier than ever before. Global 2.0 is the first complete solution targeted at automating the business processes for medical device approvals worldwide.

About StatSure Diagnostic Systems, Inc.

StatSure Diagnostic Systems is engaged in the development, manufacture and marketing of rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases; in addition, the Company has developed and is marketing a product line of patented, oral-fluid collection devices. The Company’s proprietary platforms provide significant customer benefits and competitive advantages as compared to similar products that are currently available. Improved accuracy, operator convenience, and reduced risk of infection from collecting and handling specimens, have been engineered into SDS products. All of our diagnostic tests are based on the same easy-to-use technology platform, thus facilitating the development of future products. StatSure Diagnostic System’s technology provides a quick, accurate, portable, safe and cost-effective solution.

Visit StatSure Diagnostics online at www.statsurediagnostics.com

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About clinivation

Clinivation solutions deliver the digital advantage to outperform in new business environments with innovative and better ways to succeed in global development and commercialization.

Our cross‐functional software brings people and knowledge to the point of action to eliminate revenue traps, overcome process complexity, and enable execution with full visibility, decision support, and controls.

Trusted for millions of products by hundreds of companies worldwide, our modular, interoperating applications yield new, scalable operating models that directly connect biomedical innovation with high‐value inflection points and business growth.

The world’s leading medtech, pharmaceutical, and biotech organizations partner with clinivation because of our industry expertise and our transformative solutions that seamlessly integrate existing business processes and enterprise infrastructure‐ leveraging cloud, hybrid, and on‐premises architectures.

Our vision is to inspire our shared purpose of bringing innovation to life with the value of information technology.

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Corporate Communications
irpr@clinivation.com

clinivation, Inc.
Suite 1800
245 First Street
Cambridge, MA 02142
U.S.A.
Phone +1 617‐444‐8500

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© 2025 · clinivation, INC.

Clinivation solutions deliver the digital advantage to outperform in new business environments with innovative and better ways to succeed in global development and commercialization.

Our cross‐functional software brings people and knowledge to the point of action to eliminate revenue traps, overcome process complexity, and enable execution with full visibility, decision support, and controls.

Trusted for millions of products by hundreds of companies worldwide, our modular, interoperating applications yield new, scalable operating models that directly
connect biomedical innovation with high‐value inflection points and business growth.

The world’s leading medtech, pharmaceutical, and biotech organizations partner with clinivation because of our industry expertise and our transformative solutions
that seamlessly integrate existing business processes and enterprise infrastructure‐ leveraging cloud, hybrid, and on‐premises architectures.

Our vision is to inspire our shared purpose of bringing innovation to life with the value of information technology.

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