Proving the Business Case for the Internet of Things

FDA approves Abbott remote heart monitor

Steve Rogerson
July 14, 2020



The US Food & Drug Administration (FDA) has approved Illinois-based Abbott’s heart rhythm devices that use Bluetooth connectivity for continuous remote monitoring.
 
The Gallant implantable cardioverter defibrillator devices introduced in February provide Bluetooth capability to increase the meaningful connection between patients and their doctors.
 
The Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices benefit patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility. In addition, the devices offer Bluetooth technology and a patient smartphone app for improved remote monitoring, allowing for increased patient-physician engagement and streamlined communications.
 
It is estimated that as many as 6.1 million people in the USA battle cardiac arrhythmias, or abnormal heart rhythms, and ICDs are used to help reduce the risks of life-threatening arrhythmias. For patients with heart failure or in situations when the heart's chambers beat out of sync, CRT-Ds can be used to restore the heart's natural pattern of beating.
 
"We are focused on developing and delivering life-changing technologies that impact patient care in a meaningful way," said Randel Woodgrift, senior vice president at Abbott. "The Gallant devices are the latest example of how Abbott is driving innovation to meet changing healthcare needs and helping to improve connectivity and engagement between patients and their doctors."
 
The Gallant pairs with Abbott's secure MyMerlinPulse, an iOS and Android compatible mobile smartphone app that streamlines communications between doctors and their patients. The app provides access to data, device performance and transmission history, which helps people take an active role in their healthcare. Through the app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.
 
"The ability for patients to stay connected to their doctors via their implanted device and a smartphone app has the potential to change how healthcare providers and patients communicate with each other," said Raffaele Corbisiero, director of electrophysiology at Deborah Heart & Lung Center in New Jersey. "The FDA's approval of Abbott's Gallant devices enables doctors to provide a more collaborative approach to treatment plans and the increased bond between a patient and provider will lead to better outcomes for all."
 
Abbott’s technologies span the spectrum of healthcare, with businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Its 107,000 employees serve people in more than 160 countries.