IN3 Meeting In Brief
This article was originally published in The Gray Sheet
CoaguSense: The Fremont, Calif., company hopes to win 510(k) approval for home use of its Immedia Meter to diagnose clot formation in January, CEO Douglas Patterson told investors Oct. 20 at the Investment in Innovation (IN3) Medical Device Summit in San Francisco (meeting was held Oct. 19-21 and organized by Elsevier Business Intelligence, publisher of "The Gray Sheet"). The prothrombin time/INR (international normalized ratio) assay is already available for use in providers' offices to help manage dosing for a patient on the blood thinner warfarin. Abbott bought the distribution rights for the home-based test version and plans to launch the assay by next March, pending FDA go-ahead. Medicare expanded national coverage of home-based PT/INR testing to patients taking warfarin for chronic atrial fibrillation or venous thromboembolism, and it was already covered for mechanical heart valve patients (1"The Gray Sheet" March 24, 2008). Immedia Meterrelies upon a finger-prick blood test and test strip inserted into a low-cost analyzer
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Medicare coverage is expanded for home blood testing of prothrombin time to include beneficiaries who are using the blood thinner warfarin for chronic atrial fibrillation or venous thromboembolism in a March 19 final coverage determination. Home International Normalized Ratio (INR) prothrombin time monitoring is already covered for patients with mechanical heart valves. The new policy should be a boon for three device firms that market INR assays for home use - Thoratec/International Technidyne (ProTime Microcoagulation System), Inverness/HemoSense (INRatio) and Roche Diagnostics (CaguChek XS and Coaguchek PST) ("1The Gray Sheet" Jan. 7, 2008, p. 16)
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