The FDA has cleared a portable ECG device that allows patients to capture a 30-second heart recording at home when symptoms occur, with the data sent to a physician for review and next steps.
The AI module enables fully automated segmentation of CT images in the creation of 3D cardiac models, allowing inHEART to deliver its solution to physicians with greater speed and efficiency.
The FDA granted Empatica 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.
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The CorVista System allows a physician to evaluate the patient at point-of-care for cardiac disease using a static machine-learned detection algorithm.
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London-based LivaNova has received FDA 510(k) clearance and the European Commission’s CE Mark for its Essenz In-Line Blood Monitor.
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The ECGenius System is now the only electrophysiology recording system with an AI algorithm to facilitate electrogram interpretation and deliver intelligent, automated analyses designed to help physicians improve ablation outcomes in complex atrial arrhythmia procedures by measuring the success of cardiac ablation, according to the company.
Read MoreAccurKardia’s cloud-based AccurECG analysis system receives FDA clearance, allowing rapid and precise detection of 13 heart rhythms. This advancement in remote cardiac care brings specialist-level ECG interpretation to underserved communities and enhances workflow efficiency for clinical practitioners.
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