Lexology October 27, 2023
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s Automated Impella Controller (AIC), which is part of a medical device system that provides temporary ventricular support to help a patient’s heart to pump blood in a critical care setting.
Abiomed attempted to argue that functions of the Impella Connect System were non-device clinical decision support (CDS) software functions or non-device medical device data systems, but the FDA disagreed. The FDA asserted that the software component, by providing “time-critical alarms and patient-specific medical information intended to trigger potential clinical intervention to assure patient...
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