Category: ECG & evidence
AI and sudden cardiac death: what should clinicians do with an ECG risk prediction?
A Nature study identifies an ECG signal associated with future sudden cardiac death. Its findings raise a practical development question: what action should a risk prediction support, and what evidence would justify it?
Clinical evidence planning starts with the intended use
A well-run study can still leave a device claim unanswered. Map intended use to population, outcomes and evidence gaps before deciding which clinical work to commission.
Bench, analytical and clinical evidence in a cardiovascular program
A cardiovascular device company faces complex decisions despite successful engineering results. Testing outcomes need clarity regarding their clinical relevance versus technical validation. Understanding distinctions between physical endurance, measurement accuracy, and clinical impact is crucial. Unresolved questions inform the necessary next steps for further investigation, highlighting the importance of targeted studies over generalized conclusions.
Device-agnostic ECG software: what the evidence needs to show
Why overall performance is only part of the conversation about supported devices and recording configurations.
Licensing an ECG algorithm: what remains with the manufacturer
The relationship between the licensed technology and the finished product deserves an explicit agreement.
Signal quality belongs in the performance evaluation
Plan how recording conditions and unusable data will be handled before interpreting the results.