Abbott has received approval from the US Food and Drug Administration (FDA) for its CardioMEMS HF System capabilities, introducing new digital features that allow individuals to track their cardiac data directly on mobile devices.
The regulatory clearance enables healthcare providers to grant US patients access to their pulmonary artery pressure measurements and trends through the CardioGuide HF App on Android and iOS smartphones.
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The update also adds the Dynamic Treatment Plan software feature, accessible to medical teams through the Merlin.net Patient Care Network Portal.
This tool allows clinicians to configure personalised medication adjustments based on pressure changes and send updated therapeutic instructions straight to patients via the mobile application.
The CardioMEMS HF System consists of a small sensor permanently implanted in the pulmonary artery, the CardioMEMS HERO reading unit, and the Merlin.net Patient Care Network Portal.
Individuals use the HERO hardware to record measurements, which are transmitted through the online portal to their clinical team for remote assessment.
Abbott heart failure division vice-president Katie Spayde said. “Abbott is reshaping heart failure care by bringing meaningful, actionable information directly to patients. 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 launch the CardioGuide HF App and the Dynamic Treatment Plan feature later this year.
Heart failure is described as a progressive condition that prevents the heart from pumping sufficient blood, causing fatigue, shortness of breath, and fluid retention.
Medical teams have utilised CardioMEMS pulmonary artery pressure monitoring for over a decade to guide treatment adjustments, reducing mortality risk and heart failure hospitalisations.
Recently, Abbott commercially rolled out SimpleScreen CRC in the US, introducing a blood test approved by the FDA for colorectal cancer screening.
