AspenBio Pharma submits pre-IDE information package to FDA

theflyonthewall.com

AspenBio Pharma announced that it has submitted a pre-IDE information package to the FDA for the use of the AppyScore test system to aid physicians in evaluating children and young adult patients at low risk for acute appendicitis, allowing for more conservative patient management. In conjunction with the pre-IDE package, AspenBio has scheduled a meeting with the FDA prior to the end of the third quarter to work cooperatively on the clinical and regulatory plan.

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