MedWand Device Gets 510(k) Clearance
MedWand Solutions has received 510(k) marketing clearance from the FDA for its MedWand telemedicine device for remote clinical exams.
The handheld device features sensors that detect multiple vital signs including core temperature, blood oxygen saturation and pulse rate, among other measurements. It also includes an electrocardiogram feature that has not yet been cleared by the agency.
The company said it will immediately launch the MedWand Evaluation Kit which includes the device and a tablet computer that is pre-configured for access to the cloud-based VirtualCare telemedicine platform.
The company also plans to launch two other products that use the newly cleared device, the MedWand Mobile Clinic and the MedWand Remote Clinic.