Abbott Gets FDA Approval for New CardioMEMS Features

The FDA has approved new features for Abbott’s CardioMEMS HF System, allowing patients in the United States to view their pulmonary artery pressure readings on their smartphones; the update also lets care teams send personalised medication instructions through Abbott’s CardioGuide HF App.

CardioMEMS uses a small sensor implanted in the pulmonary artery to measure pressure and send readings to a patient’s care team. Abbott states that an increase in pulmonary artery pressure can indicate that heart failure is getting worse several weeks before the symptoms appear, which enables clinicians to alter treatment earlier.

Patients can now see their pressure readings.

The new CardioMEMS update adds a patient-facing layer to a system traditionally used by clinicians for remote monitoring. Using the CardioGuide HF App, care teams enable patients to view their pulmonary artery pressure readings and trends on an iOS or Android smartphone; the implanted CardioMEMS sensor provides the readings and gives patients direct access to the information their care teams use to monitor changes in their condition.

The change doesn’t shift treatment decisions away from clinicians; instead, it gives patients greater visibility into the measurements used in their heart failure care and helps them stay connected with their care teams between visits.

The app can also share medication plans.

The approval also includes Dynamic Treatment Plan, a software feature that enables clinicians to create personalised medication adjustment plans based on changes in pulmonary artery pressure.

Once a clinician activates a plan, the app will send medication-adjustment instructions to the patient via the CardioGuide HF App. The system does not determine which medication the patient should take; the care team controls the treatment plan, while the app provides the patient with relevant instructions. This means the update is primarily about communication rather than automated treatment: CardioMEMS still supplies the physiological measurement, clinicians interpret the information and decide on the appropriate course of action, and the app gives patients a direct way to receive that advice.

The update builds on an already established system.

CardioMEMS has been used for over ten years to monitor pulmonary artery pressure in individuals with heart failure; the system includes an implanted pressure sensor, the CardioMEMS HERO device that takes the readings, and Abbott’s Merlin.net Patient Care Network Portal, which sends the data to the care team.

The FDA previously approved the CardioGuide HF Application as part of an earlier CardioMEMS system supplement. The FDA record identifies the CardioGuide HF Application as part of supplement S077 for the CardioMEMS HF System. The most recent approval introduces new features for patients on the existing platform. Abbott intends to make the CardioGuide HF App and Dynamic Treatment Plan available later in 2026.

A more direct role for patients

The update moves some remote monitoring data closer to the patient. Previously, care teams primarily used pulmonary artery pressure readings to track changes and guide treatment. The new app gives patients access to their own readings and trends, as well as treatment instructions from their clinicians.

For Abbott, the change extends CardioMEMS’s role without altering its fundamental purpose: the implanted sensor still gathers pressure measurements, doctors still make treatment decisions, and the app creates a more direct link between those decisions and the patient. The full practical impact won’t become evident until the new features are available later this year, and their value will depend on how care teams integrate the tools into routine heart failure management and how patients use the extra information between visits.