St. Jude Medical said the FDA cleared its SJM Confirm implantable cardiac monitor (ICM), a compact device designed to help physicians diagnose abnormal heart rhythms.
The implantable monitor enables physicians to evaluate heart rhythm signals over a longer period of time than allowed by standard monitoring tests, and is designed to help them diagnose and document difficult-to-detect rhythm disorders in patients who may suffer from unexplained symptoms, including syncope (the sudden and transient loss of consciousness), palpitations and shortness of breath.