FDA Clears Mobile App for Contactless Pulse Rate Measurement
The app uses an iPhone or iPad camera to measure pulse rate in 30 seconds.
Tag: FDA 510(k) clearance
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FDA Clears AI to Detect Heart Failure During Routine Check-ups
The AI-enhanced digital stethoscope enables healthcare providers to detect low ejection fraction, a key indicator of heart failure, within 15 seconds during a standard physical exam.
FDA Clears SimpleSense Continuous Blood Pressure Monitor
The US Food and Drug Administration has granted FDA 510(k) clearance to Nanowear’s SimpleSense, an artificial intelligence-enabled non-invasive, cuffless continuous blood pressure monitor and diagnostic.
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FDA Clears Empatica’s Platform for Cardiac Digital Biomarkers
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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FDA Clears CorVista System to Detect Cardiac Disease
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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Essenz In-Line Blood Monitor Receives FDA Clearance and CE Mark
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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FDA Clears AI-Powered EP Recording System to Measure Cardiac Ablation Success
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 Automated ECG Analysis System Receives FDA Clearance
AccurKardia’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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