At some point in the future, FDA clearance for wearable or handheld digital healthcare devices won’t be newsworthy, but we’re not there yet. We are at the end of summer 2022, and when the FDA clears a digital device for remote vital signs measurement or monitoring, it’s still kind of a big deal. The FDA doesn’t approve medical devices unless the manufacturer convinces the agency the device is equal to or better than existing solutions. Put another way, FDA clearance to market a medical product indicates the device results are valid and reliable. Devices presented as alternatives to conventional solutions have to meet clinical-grade performance standards. MedWand Solutions, a southern California and Las Vegas based digital healthcare technologies company, recently announced FDA 510(k) clearance for the MedWand, which is a handheld device and medical ecosystem for telemedicine.
The MedWand device reports multiple clinical-grade vital signs measurements. The device monitors core temperature, blood oxygen saturation, and pulse rate. The device can record medically relevant heart, lung, and abdominal sounds. Healthcare professionals can also use the device to capture electrocardiograms and otoscopic, oropharynx, and dermatoscopic exam images. When connected to FDA-approved third party solutions, the MedWand can also report blood pressure, blood glucose level, weight, body mass, and lung test results.
The MedWand’s native device capabilities and third party connections produce a ton of varied data. MedWand’s Virtual Care Clinic software is an ecosystem that links to patient records, medical records, and practice management platforms. According to a recent news release, the platform will also adapt to future AI applications to enhance telemedical services.
FDA approval for a single device that can monitor such a wide range of medical data remotely enables potential applications in mobile clinics, expanding healthcare access to hitherto nearly underserved populations including schools, workplaces, nursing homes, and even in hospitals. When every desired biometric requires its own patient landscape, things can get pretty crowded. A product such as the MedWand simplifies matters by providing a single source solution for remote physical exams.
