AliveCor’s KardiaMobile 6L becomes the first personal ECG device recommended by NICE

NICE Early Value Assessment recommends use of the smartphone-based portable KardiaMobile 6L ECG device in psychiatric services in England and Wales as an option to measure cardiac QT interval as a safety screening for adults having antipsychotic medication. 

AliveCor, an innovator in personal electrocardiogram (ECG) technology, has announced its KardiaMobile^® 6L is the first smartphone-based personal ECG to be conditionally recommended for use in England and Wales by the National Institute for Health and Care Excellence (NICE), as part of its Early Value Assessment (EVA) pilot project. The portable KardiaMobile 6L has been recommended for use in psychiatric services, in hospital or home visits, as an option to measure cardiac QT interval for adults having or about to have antipsychotic medication, subject to the generation of additional evidence.  

People taking antipsychotic medication are at increased risk of severe cardiac events and there is an unmet need for more accessible and available measurements for detecting cardiac abnormalities in psychiatric services. A prolonged QT interval indicates an abnormality detected on an ECG. 

“Timely ECG monitoring of patients who are on antipsychotic medication can save lives. Having access to KardiaMobile 6L will mean potentially vulnerable patients can now be seen in the comfort of their homes, reducing their stress whilst ensuring that this essential monitoring is completed anywhere, at any time. It is encouraging that NICE has recognized the need for early access to this important technology,” commented Dr Mani Krishnan, Consultant Psychiatrist and Specialty Clinical Director, Tees, Esk and Wear Valleys NHS Foundation Trust. 

The aim of NICE’s EVA pilot project is to drive earlier access to promising healthcare innovations for use within the National Health Service in England and Wales.  

“We are delighted that KardiaMobile 6L has been recognized by NICE and reviewed by the EVA pilot project. This decision is testament to the clinical importance of detecting and monitoring heart disturbances both in clinic and at home, something especially important in psychiatric services,” said Sean Warren, Business Director UK&I, AliveCor.  

NICE’s decision was based on a systematic review of eight studies that evaluated the technical performance of KardiaMobile 6L compared with a traditional 12-lead device. 

KardiaMobile 6L is a 6-lead portable ECG recording device that provides instant detection of a range of cardiac abnormalities and can be used to measure heart changes, including cardiac QT interval. It can be used by healthcare professionals in both a hospital setting and as part of routine home visits. Real-world test completion in familiar home surroundings is advantageous as it eliminates need for travel and may reduce stress and anxiety amongst psychiatric patients. KardiaMobile 6L also removes the requirement for conductive gel and undressing, which can cause reluctance and distress for patients. KardiaMobile 6L has the potential to ensure timely ECG testing is available that could help adults having antipsychotic medication get faster access to safe and effective antipsychotic treatment. 

 A condition of NICE’s positive recommendation is that further evidence on the use of this innovative technology in psychiatric services must be generated to inform a further full technology reassessment. 

“We have a wealth of clinical data on the use of KardiaMobile 6L in cardiology, with NICE’s EVA recommendation we will now support the collection of real-world evidence as to its effectiveness in psychiatric services,” forecast Sean Warren, Business Director UK&I, AliveCor. “We applaud NICE and the physicians that have worked on this project for their forward-thinking approach to the use of novel health tech within the NHS, as we know it is patients that will be the ultimate beneficiaries.”