Abbott Gains FDA Approval for CardioMEMS Update Letting Heart Failure Patients View Pressure Readings on Their Phones

The FDA has approved updates to Abbott’s CardioMEMS HF System that will allow patients with an implanted sensor to view their pulmonary artery pressure (PAP) readings on a smartphone and receive individualized treatment plan updates, the company announced October 5. The patient-facing features, delivered through the CardioGuide HF app, are expected to become available later this year.¹

The approval adds capabilities to the existing remote monitoring system. CardioMEMS readings are transmitted to clinicians to guide heart failure treatment; with the new app, care teams can also enable patients to see their own readings and trends on an iOS or Android phone.¹

A second feature, Dynamic Treatment Plan, allows clinicians to establish personalized medication adjustment plans through Abbott’s Merlin.net Patient Care Network Portal. When enabled by the care team, medication instructions based on changes in PAP can be sent to the patient’s app. The release describes clinician-directed plans; it does not say the app independently determines medication changes.¹

The implanted CardioMEMS sensor measures PAP, which may rise before patients notice shortness of breath, edema, or weight gain. Patients use the CardioMEMS HERO device to obtain readings, which are transmitted to the clinical team through Merlin.net. The app adds a patient view of those readings to the existing clinician monitoring workflow.¹

“Pulmonary artery pressure readings can help identify changes earlier, giving care teams an opportunity to adjust treatment before symptoms develop,” Andrew J. Sauer, MD, a cardiologist at Saint Luke’s Mid America Heart Institute and professor of medicine at the University of Missouri–Kansas City, said in Abbott’s release.¹

The CardioMEMS HF System is indicated to measure and monitor PAP and heart rate in patients with New York Heart Association class II or III heart failure who have had a heart failure hospitalization in the previous year and/or have elevated natriuretic peptides.² Prior studies have evaluated outcomes with PAP-guided management, but Abbott did not report a clinical outcomes study of the newly approved app features. Their effects on hospitalization, adherence, and patient engagement remain to be established.¹˒²

Abbott did not provide an exact US launch date or pricing information for CardioGuide HF or Dynamic Treatment Plan.¹

References:

1. Abbott. Abbott receives FDA approval for new CardioMEMS HF System capabilities that help patients engage in the care of their heart condition. News release. October 5, 2026. Accessed October 8, 2026. https://abbott.mediaroom.com/2026-10-05-Abbott-receives-FDA-approval-for-new-CardioMEMS-HF-System-capabilities-that-help-patients-engage-in-the-care-of-their-heart-condition