Abbott gets FDA approval for new CardioMEMS app features

Abbott announced on October 5, 2026, that the U.S. Food and Drug Administration cleared new patient-facing capabilities for its CardioMEMS HF System. The regulatory clearance enables care teams to let heart failure patients view their pulmonary artery pressure readings directly on iOS and Android smartphones through the CardioGuide HF App.

The updates also include Dynamic Treatment Plan, a software feature in the Merlin.net Patient Care Network Portal. This tool lets medical teams set personalized medication adjustment plans based on pressure trends and deliver instructions directly to patients through the app. Pulmonary artery pressure often rises weeks before patients experience symptoms such as swelling, shortness of breath, or weight gain.

Abbott stated that it plans to make the CardioGuide HF App and the Dynamic Treatment Plan feature available later in 2026. The CardioMEMS system uses an implanted pulmonary artery sensor and the CardioMEMS HERO device to track hemodynamic data, which has been used by clinicians for more than a decade to lower heart failure hospitalizations and mortality risk.