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.