Abbott CardioMEMS Wins FDA Approval for Patient-Facing App Features

Abbott announced on Oct. 5, 2026 that the U.S. Food and Drug Administration has approved updates to the CardioMEMS HF System that enable new patient-facing capabilities through the company’s CardioGuide HF App. For the first time, care teams can allow U.S. CardioMEMS patients to view their pulmonary artery pressure (PAP) readings directly on their smartphones.

The CardioGuide HF App is a mobile application for people living with heart failure who have an implanted CardioMEMS pulmonary artery pressure sensor. It displays a patient’s own PAP readings and trends on an iOS or Android smartphone. Abbott said it plans to make the CardioGuide HF App and a companion software feature, Dynamic Treatment Plan, available later this year.

Pulmonary artery pressure is the pressure of blood flowing from the right side of the heart into the lungs. According to Abbott, rising PAP is one of the earliest signs of worsening heart failure and can occur weeks before a patient experiences symptoms. For more than a decade, clinicians have used PAP readings from the CardioMEMS HF System to help identify signs of worsening heart failure and guide treatment.

The CardioMEMS HF System measures PAP through a small sensor implanted permanently in the pulmonary artery. The system also includes the CardioMEMS HERO device, which patients use to take pressure readings, and the Merlin.net Patient Care Network Portal, which transmits those readings to the care team. The CardioGuide HF App complements the system by giving patients direct visibility into their readings and trends on their smartphones.

Dynamic Treatment Plan

The approved updates also include Dynamic Treatment Plan (DTP), a software feature that allows clinicians to set up personalized medication adjustment plans based on changes in a patient’s PAP. Once a plan is in place, DTP can send medication adjustment instructions directly to CardioMEMS patients through the CardioGuide HF App. The feature is available through Abbott’s Merlin.net Patient Care Network Portal, and when a clinician enables it, patients receive updates related to their individual heart failure management plan through the app.

“Heart failure can worsen before patients notice shortness of breath, swelling or weight gain. Pulmonary artery pressure readings can help identify changes earlier, giving care teams an opportunity to adjust treatment before symptoms develop,” said Andrew J. Sauer, M.D., cardiologist and vice president for research at Saint Luke’s Mid America Heart Institute and professor of medicine at the University of Missouri-Kansas City.

“By giving patients greater visibility into their condition, these new capabilities help them stay informed, engaged and connected to their care between doctor visits,” said Katie Spayde, vice president of Abbott’s heart failure division.

Posted Indication and Safety Information

The system’s posted U.S. indications and safety information state that the CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.

The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant. Listed potential adverse events associated with the implantation procedure include air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolism, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.

Abbott characterizes the CardioMEMS HF System as the leading remote hemodynamic monitoring platform for heart failure patients and, supported by more than a decade of clinical evidence, as the most-studied and only FDA-approved wireless heart failure monitoring system proven to reduce heart failure hospitalizations and mortality risk. Studies the company cites in support of those claims are Heywood et al. in J Card Fail (2023), Adamson et al. in Circ Heart Fail (2016), a Lindenfeld et al. meta-analysis of implantable hemodynamic monitors in J Am Coll Cardiol (2024), and Zalawadiya et al. in JACC Heart Fail (2025).

The October announcement follows Abbott’s Feb. 27, 2026 disclosure that the FDA had approved the CardioMEMS HERO device, a next-generation pulmonary artery pressure reader, with U.S. commercial release to begin soon. Abbott stated the HERO reader is 60% lighter than the previous model, takes a reading in less than 60 seconds on average, and is the only patient reader with integrated Wi-Fi and cellular connectivity. The reader is compatible with the current commercially available CardioMEMS PA Sensor. Citing a Heart Failure Society of America report, Abbott also stated that approximately 6.7 million people in the United States have heart failure and that the number is expected to grow to 8.5 million by 2030.