Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
QNY · Not classified · Unknown
Classification
FDA Product Code
QNY
Device class
Not classified
Regulation
—
Review panel
CV
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
To be used by healthcare professionals (HCP) in the hospital setting for remote monitoring and detection of changes in the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment with drugs that can prolong QT intervals and may cause life threatening arrhythmias. Device used during declared public health emergency.