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The MedWand™ Device, in combination with the MedWand™ Software Application installed on an attached mobile device or computing system, is an intermittent vital sign measuring and examination system intended to collect, record, and display the following information: - · Oxygen saturation (SpO2), - · Pulse rate (PR), - · Infrared body temperature (TEMP) - · Amplified auscultation sounds filtered for heart, lungs, and abdomen (STETH) - · Photographs of areas needing assessment (CAMERA) The device is intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical environments. The MedWand™ Device is intended for use by trained adults only who can use smart phones, tablets, or computers proficiently. Collected information is not intended for self-diagnosis. Interpretation and assessment of results should be performed by an HCP. Collected information can be provided to a HCP when used as a standalone device. Additionally, the MedWand™ Device can integrate with external data communications systems (not part of the MedWand™ Device) through a programming interface. This integration will facilitate interactions between the lay user and HCP for telemedicine. The device is intended for spot-checking and does not have continuous monitoring capability or alarm features.

The MedWand™ Device is a handheld telemedicine device that allows measurement of SpO2. pulse rate, and stethoscope along with a camera. The device is intended to be used by lay people or clinical personnel. The patient applies their finger to the sensor on the top of the device designed for measuring SpO2 and pulse rate. The thermometer is a non-contact IR thermometer that is pointed to the patient's forehead. The camera can be pointed to the particular body part at the (remote) Health Care Professional's (HCP) direction. The stethoscope is contacted directly to the patient's chest or abdomen to provide auscultation sounds to the (remote) HCP. The MedWand™ Device works as part of the MedWand™ Ecosystem. The MedWand™ Ecosystem consists for following elements: - 1. MedWand™ Device including its embedded firmware This device is provided to the patient or other user who is physically present with the patient. - 2. USB-C cable provided with the device. This cable physically connects the MedWand™ Device to the mobile device or computing platform to provide power, communications, and control for the MedWand™ Device - 3. Client App Software Proprietary software that is provided to the patient or user to run on their mobile device or computing platform (MCP). This software is available for both Windows-based and Android-based devices. This software supports the local operation of the MedWand™ Device and the use of the device in the context of a telemedicine system. This software contains the user interface to the MedWand™ Device. This software provides the user with the concept of a session in which the user activates one or more sensors, collects readings for temperature and pulse oximeter, photos from the camera, and recordings from the stethoscope. - 4. Device Communications Module (DCM) The DCM runs on the MCP incorporated as a library in the Client App. The DCM manages the serial communications between the MedWand™ Device and MCP. The DCM is also known as the Software Developer's Kit (SDK), as it provides a controlled programming interface to enable integration with thirdparty telemedicine systems. - 5. A mobile device (e.g., laptop, tablet or smartphone) or computing platform (laptop or computer) (collectively Mobile Computing Platform (MCP)) – The MCP is supplied by the patient or user, not by MedWand. The Client App proprietary software runs the MCP. The MCP is not part of the medical device. - 6. A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not supplied by MedWand and not part of the medical device). As described in the cited FDA guidance, this platform and any clinician interface are not part of the medical device. - 7. Commercial Telemedicine systems provides real-time voice and video communications between the HCP and the MedWand™ Device user (as patient) in a virtual live visit. These external software systems would be classified as Medical Device Data Systems, which FDA no longer considers medical devices.