Abbott’s Bluetooth connected cardioverter defibrillator and cardiac resynchronization therapy defibrillator, part of the Gallant product line, scored FDA clearance this morning.
Patients using the technology can connect it to a smartphone app, called MyMerlinPulse, which will let both patients and providers see transmission history and device performance. The app is also designed to nudge patients to set up their next doctor’s appointment. Doctors are able to tap into the app in order to remotely monitor patients and detect any potentially problematic events.
This FDA designation includes the MyMerlinPulse App and the software to program the Gallant family of devices on the programmer, according to a company spokesperson.
The tool landed a European CE mark in February, and is geared towards individuals with reduced cardiac function.
WHY IT MATTERS
Heart conditions are common in the US. In fact, atrial fibrillation impacts between 2.7 million and 6.1 million people in the United States, according to the CDC. The company is pitching this product as another way for doctors to monitor their patients' heart conditions remotely.
"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," Dr. Raffaele Corbisiero, director of electrophysiology and pacing at Deborah Heart and Lung Center, Browns Mills, said in a press statement. "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."
THE LARGER TREND
This isn’t Abbott’s first foray into cardiac monitoring. In 2017, the FDA cleared its Confirm Rx Insertable Cardiac Monitor (ICM), an implantable device that is able to track a patient’s heart rhythms and send the data to a smartphone app via Bluetooth.
This was shortly followed by Abbott subsidiary St. Jude Medical gaining FDA clearance for MyMerlin companion app to its Confirm Rx Insertable Cardiac Monitor.
However, Abbott’s experience in the digital health space goes beyond just cardiac care. It has long been known for its role in the diabetes care. In fact, in June it announced the FDA clearance of the continuous glucose monitoring system the FreeStyle Libre 2.
It has also dipped into neurological care. It also launched a system where its deep brain stimulation device can connect to an iPad mini where clinician can program their patient’s therapy and monitor outcomes.