FDA warns J&J's Abiomed over its heart pumps

The FDA sent a warning letter to Abiomed, Johnson & Johnson's heart device company, for marketing the Impella Connect app without premarket approval. 

The Impella heart pumps are used in critical care settings to help a patient's heart pump blood, and they can be monitored remotely through the app. 

Abiomed told the FDA these devices are classified as Non-Device Clinical Decision Support Software and Non-Device Medical Device Data Systems, but the regulatory agency disagrees. 

"Though some functions of the Impella Connect System may be Non-Device-MDDS [the product's alarms] provide patient-specific medical information to detect a life-threatening condition and display time-critical alarms intended to notify a healthcare provider," the FDA said in its Oct. 10 letter. Because of this, the Impella pumps require premarket approval. 

Abiomed is working with the FDA, a spokesperson said.

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