The approval allows patients with neurological conditions such as chronic pain or movement disorders to manage therapy, using their personal smartphone and eliminate the need for separate patient programmer device.
It serves as an important step in the integration and connection of digital health tools that ultimately help patients live fuller and healthier lives, the company noted.
The Patient Controller app has been designed to be integrated into Abbott’s NeuroSphere Digital Care connected care management platform, which was launched in May.
It is compatible with the company’s suite of neuromodulation technologies, including Infinity DBS System, Proclaim XR SCS System and Proclaim DRG Neurostimulation System.
The capability for technology integration enables physicians to offer personalised treatments to patients within their practice.
Abbott Neuromodulation vice-president Keith Boettiger said: “With the continuing rise in interest and demand for these technologies, Abbott, as a pioneer in patient-centric neuromodulation technology, is advancing the field of digital health to deliver on the promise of digital care.
“The approval of Abbott’s Patient Controller app with personalised access to therapy is a landmark event as we are now able to provide patients a way to access personalised therapy from a compatible and secure iOS device so that people can live their lives and seamlessly manage conditions like chronic pain and movement disorders.”
Abbot expects to roll out the Patient Controller app with personalised access to therapy in the next few weeks.
Earlier this month, the company received the FDA approval for the Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.