Abbott receives FDA approval for new CardioMEMS HF System capabilities that help patients engage in the care of their heart condition

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Oct 05, 2026, 09:00 ET

For the first time, U.S. CardioMEMS patients will be able to view pulmonary artery pressure (PAP) readings and receive personalized medication updates through the CardioGuide HF App
Rising PAP can signal worsening heart failure weeks before patients experience symptoms
New capabilities help patients take a more active role in their care and stay connected to their care teams between doctor visits

ABBOTT PARK, Ill., Oct. 5, 2026 /PRNewswire/ -- Abbott (NYSE: ABT), the global healthcare leader, today announced U.S. Food and Drug Administration (FDA) approval for updates to the CardioMEMS HF System that enable new patient-facing capabilities through the 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, giving them greater insight into their condition and helping them take a more active role in their care.

Heart failure can worsen long before symptoms become noticeable. Pulmonary artery pressure — the pressure of blood flowing from the heart to the lungs — can rise as heart failure worsens, often weeks before patients experience any symptoms. The CardioMEMS HF System, which has been shown to reduce heart failure hospitalizations^2,3 and mortality risk^4,5, measures pulmonary artery pressure through an implanted sensor in the pulmonary artery. For more than a decade, clinicians have used pulmonary artery pressure readings from the CardioMEMS HF System to help identify signs of worsening heart failure and guide treatment.

Building on that clinical experience with CardioMEMS, Abbott is continuing to evolve heart failure management with digital tools that help keep clinicians and patients connected between office visits. The CardioMEMS HF System with the CardioGuide HF App represents an important step toward helping patients take an earlier, more active role in understanding and managing their heart failure.

"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 access to their pressure trends and personalized guidance from their care team, the CardioGuide HF App can help patients better understand their condition, understand why treatment adjustments are recommended, and take a more active role in managing their heart failure."

The new CardioMEMS HF System capabilities 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 pulmonary artery pressure. Once in place, DTP can send medication adjustment instructions directly to CardioMEMS patients through the CardioGuide HF App, ensuring patients receive timely feedback and guidance from their care team.

"Abbott is reshaping heart failure care by bringing meaningful, actionable information directly to patients," said Katie Spayde, vice president of Abbott's heart failure division. "For many people living with heart failure, managing their condition is part of everyday life. By giving patients greater visibility into their condition, these new capabilities help them stay informed, engaged and connected to their care between doctor visits."

Abbott plans to make CardioGuide HF App and Dynamic Treatment Plan available later this year.

Frequently Asked Questions

What is heart failure?
Heart failure is a chronic, progressive condition in which the heart is unable to pump enough blood to meet the body's needs. It can cause shortness of breath, fatigue and swelling, and tends to worsen over time. Heart failure affects millions of people worldwide and is a leading cause of hospitalization.

What is pulmonary artery pressure, and why does it matter in heart failure?
Pulmonary artery pressure is the pressure of blood flowing from the right side of the heart into the lungs. Rising pulmonary artery pressure is one of the earliest signs of worsening heart failure, often before a patient feels any symptoms. Monitoring pulmonary artery pressure remotely helps clinicians detect these changes early and adjust treatment before hospitalization is needed.

What is the CardioGuide HF App?
The CardioGuide HF App is a mobile app for people living with heart failure who have a CardioMEMS pulmonary artery pressure sensor. The app displays a patient's own pulmonary artery pressure readings and trends on their iOS or Android smartphone.

How does the CardioGuide HF App work with the CardioMEMS HF System?
The CardioMEMS HF System includes an implanted pulmonary artery pressure sensor, the CardioMEMS HERO device and the Merlin.net Patient Care Network Portal.

Individuals implanted with a CardioMEMS sensor can use the CardioMEMS HERO device to take pressure readings, which are transmitted to their care team through the Merlin.net Patient Care Network Portal. The CardioGuide HF App complements the system by giving patients direct visibility into their pulmonary artery pressure readings and trends on their smartphones.

Together, the CardioMEMS HF System and CardioGuide HF App help keep both clinicians and patients informed and engaged in heart failure management.

What is the Dynamic Treatment Plan?
Dynamic Treatment Plan (DTP) is a feature available through Abbott's Merlin.net Patient Care Network Portal that enables care teams to communicate treatment plan updates directly to CardioMEMS patients through the CardioGuide HF App. When enabled by a clinician, patients can receive updates related to their individual heart failure management plan through the CardioGuide HF App.

About the CardioMEMS HF System
Abbott's CardioMEMS HF System is the leading remote hemodynamic monitoring platform for heart failure patients. The system features a small pressure-sensing device implanted permanently in the pulmonary artery. The device allows clinicians to remotely monitor pulmonary artery pressure through the Merlin.net Patient Care Network Portal and proactively adjust treatment before hospitalization is needed. Supported by more than a decade of clinical evidence, CardioMEMS is the most-studied¹ and only FDA-approved wireless heart failure monitoring system proven to reduce heart failure hospitalizations^2,3 and mortality risk^4,5. Additional information about the CardioMEMS HF System is available here.

Indications and Important Safety Information
For U.S. important safety information on the CardioMEMS HF System, visit: Indications, Safety and Warnings for the CardioMEMS HF System.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X, and YouTube.

¹Abbott. Data on file.
²Heywood JT, Zalawadiya S, Bourge RC, et al. Sustained reduction in pulmonary artery pressures and hospitalizations during 2 years of ambulatory monitoring. J Card Fail. 2023;29(1):56–66. doi: 10.1016/j.cardfail.2022.10.422.
³Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary artery pressure-guided heart failure management reduces 30-day readmissions. Circ Heart Fail. 2016;9(6):e002600. doi:10.1161/CIRCHEARTFAILURE.115.002600.
⁴Lindenfeld J, Costanzo MR, Zile MR, et al., on behalf of the GUIDE-HF, CHAMPION, and LAPTOP-HF Investigators. Meta-Analysis of Implantable Hemodynamic Monitors for HFrEF. Implantable hemodynamic monitors improve survival in patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2024;83:682-694. doi:10.1016/j.jacc.2023.11.030.
⁵Zalawadiya S, Abraham J, Rathman L, et al. Early reduction of pulmonary artery pressures is associated with improved mortality among Medicare beneficiaries with heart failure. JACC Heart Fail. 2025;13(10):102589. doi:10.1016/j.jchf.2025.102589.