FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Shire Web-Based Dosing Software Achieves FDA Clearance

Dec. 28, 2017
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Shire received 510(k) marketing clearance for its web-based dosing software for patients with hemophilia A treated with ADVATE.

The mPKFit estimates a patient’s pharmacokinetic profile using just two measurable blood samples — compared to the 9 to 11 samples recommended by the International Society on Thrombosis and Haemostasis — enabling clinicians to tailor treatments to the individual patients.

The severity of hemophilia A is determined by assessing the amount of factor in the blood, with more severity associated with lower amounts of factor.

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