PositiveID Corporation Submits FDA 510(k) Application for Its iglucose(TM) Mobile Health System for Diabetes Management
iglucose mhealth system Enables People With Diabetes to Automatically Record and Share Their Blood Glucose Readings With Family Members, Caregivers and Healthcare Professionals
DELRAY BEACH, Fla., July 11, 2011 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (Nasdaq:PSID), a leading developer of medical technologies for diabetes management, clinical diagnostics and bio-threat detection, announced today it has submitted its 510(k) pre-market notification application for its iglucose™ mobile health system for diabetes management to the U.S. Food and Drug Administration ("FDA"). PositiveID's iglucose is a wireless communication system that facilitates diabetes management by automatically creating electronic logs and journals of blood glucose readings to help ensure patient compliance
and data accuracy, as well as to aid in insurance reimbursement.
iglucose uses mobile technology to revolutionize and simplify the way people with diabetes manage their condition. By seamlessly communicating blood glucose readings from an individual's data-capable glucometer to the iglucose diabetes management portal, glucose readings can be shared automatically with family members, caregivers and healthcare professionals. iglucose eliminates the burden of keeping logbooks and empowers people with diabetes to be more engaged in the self-management of their condition.
"This submission of our iglucose mobile health system to the FDA represents the culmination of our development efforts over the last year and a half," said Scott R. Silverman, Chairman and CEO of PositiveID. "We are very proud to submit this application and have lined up the appropriate partnerships that, we believe, will ensure a successful launch and commercialization of this innovative system, both in the U.S. and abroad."
For years the American Diabetes Association and Centers for Disease Control and Prevention have recommended that individuals with diabetes self-monitor and take a record of their readings to their healthcare professionals. An American Association of Diabetes Educators positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not have the time to keep journals. iglucose solves this problem by automatically creating logs and trend reports and communicating this information, with the user's consent, to family members and healthcare professionals.
In addition to iglucose, the Company continues the development of its other diabetes management projects including the non-invasive Easy Check™ breath glucose detection device and GlucoChip™ glucose-sensing implantable microchip.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The Centers for Disease Control and Prevention predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S., according to a study published in the British journal Lancet. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. was estimated at $174 billion in 2007.
For more information on iglucose, please visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and biological detection systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MicroFluidic Systems, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
The PositiveID Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7717
Statements about PositiveID's future expectations, including the likelihood that its 510(k) application for its iglucose system will receive clearance by the FDA; the ability of iglucose to facilitate diabetes management by automatically creating electronic logs and journals of blood glucose readings to help ensure patient compliance and data accuracy, as well as to aid in insurance reimbursement; the ability of iglucose to use mobile technology to revolutionize and simplify the way people with diabetes manage their condition; the ability of iglucose to eliminate the burden of keeping logbooks and empower people with diabetes to be more engaged in the self-management of their condition; the likelihood that the Company has lined up the appropriate partnerships that will ensure a successful launch and commercialization of
this innovative system, both in the U.S. and abroad; the likelihood that iglucose has solved the problem of people not having time to keep journals by automatically creating logs and trend reports and communicating this information, with the user's consent, to family members and healthcare professionals; the ability of the Company to continue the development of its other diabetes management projects including the non-invasive Easy Check breath glucose detection device and GlucoChip glucose-sensing implantable microchip; the likelihood that according to the Centers for Disease Control and Prevention that nearly 30 percent of children born after the year 2000 will develop diabetes; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; and all other statements in this press release other than historical facts are
"forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to receive FDA clearance of its 510(k) submission for its iglucose system; the Company's ability to successfully launch and commercialize the iglucose system in the U.S. and abroad; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth
in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Q filed on May 13, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
CONTACT: Allison Tomek
Source: PositiveID Corporation
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