FDA Approves Companion Diagnostic For Obesity Drug
The US FDA has given thumbs-up to a genetic test from PreventionGenetics, the first agency-approved class II molecular companion diagnostic that looks for genetic deficiencies associated with obesity.
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The US FDA has updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.
Abbott Medical has recalled several models of its implantable pulse generators (IPGs). The devices are part of the company’s Proclaim neurostimulation systems, which deliver low-intensity electrical impulses to nerve structures.
The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.