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Home » Abbott wins FDA approval for Bluetooth heart rhythm devices

Abbott wins FDA approval for Bluetooth heart rhythm devices

July 6, 2020 By Sean Whooley

AbbottAbbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.

The next-generation devices offer a patient-preferred design with Bluetooth technology and a new patient smartphone app while sidestepping any compromise of battery longevity and MRI compatibility, according to a news release.

Gallant, which received CE Mark approval in February, pairs with Abbott’s myMerlinPulse mobile smartphone app designed to streamline communication between doctors and patients to enhance remote monitoring and enable physicians to identify asymptomatic episodes of cardiac arrhythmias or abnormal heart rhythms, leading to earlier intervention.

In a news release, Mills, N.J.-based Deborah Heart & Lung Center director of electrophysiology and pacing Dr. Raffaele Corbisiero said the capabilities offered by Gallant could “change how healthcare providers and patients communicate with each other,” and improve patient outcomes for all.

“We are focused on developing and delivering life-changing technologies that impact patient care in a meaningful way,” Abbott senior VP of cardiac rhythm management Randel Woodgrift said. “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.”

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Health Technology, Patient Monitoring, Regulatory/Compliance, Software / IT Tagged With: Abbott, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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