FDA finalizes Class II status for HeartFlow’s FFRct software

HeartFlow‘s non-invasive CT-guided fractional flow reserve software has been reclassified as a class II medical device by the FDA, according to a posting from the agency published today. The FDA classifies medical devices dependent upon based on their “risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.” HeartFlow’s FFRCT test uses data from a standard CT scan to create a 3D map of the changes in blood flow as it passes across a coronary lesion. The Redwood City, Calif.-based company submitted a request for reclassification of the software in November 2013, according to the FDA’s posting. The FDA gave the device the generic title of “coronary vascular physiologic simulation software device,” and produced a list of identified risks for such devices and required mitigation measures. The agency identified the possibility of “false negative results improperly indicating diseased vessel as low probability for significant disease” which can lead to delays in treatment as a risk for the software. The FDA said it will require software verification, validation, hazard analysis, clinical and non-clinical testing to mitigate the risk. The federal watchdog referenced the chance of false positive results improperly indicating high-probability of disease, which could lead to incorrect patient management as a risk for such devices. The agency said it would require consistency evaluat...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Software / IT HeartFlow Source Type: news