Remote or wearable patient monitoring devices include (1) non-invasive remote monitoring devices that measure or detect common physiological parameters and, (2) non-invasive monitoring devices that wirelessly transmit patient information to their health care provider or other monitoring entity. The FDA has issued EUAs for certain remote or wearable patient monitoring devices to help increase the availability of monitoring and treatment of patients and to help address reduction of healthcare provider exposure to SARS-CoV-2 during the COVID-19 pandemic.
The table below lists the remote or wearable patient monitoring devices authorized for use during the COVID-19 public health emergency.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
|Date EUA Issued||Device Type||Letter of Authorization||Fact Sheets||Other Documents||Assigned Product Code|
|04/21/2020||Remote Patient Monitor||IntelliVue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH||QLJ|
|04/26/2020||Remote Patient Monitor||VitalConnect, Inc., VitalPatch||QNY|
|05/05/2020||Remote Patient QT Interval Monitor||PhysiolGuard, ECG-QT Analysis System||QNY|
|05/08/2020||Patient Isolation Transport Unit (PITU)||Patient Isolation Transport Unit (PITU) Device||QLE|
|05/11/2020||Nurse Call System||Ascom(US), Inc., teleCARE||QNZ|
|05/14/2020||Remote Patient QT Interval Monitor||G Medical Innovations, Ltd., VSMS Patch||QNY|