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The SmartByte device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range of 27-35 kg/m² in conjunction with behavioral modification instruction.

The Scientific Intake SmartByte device is an oral removable palatal space occupying device that includes a temperature recording sensor to monitor usage. The device includes a Palatal Mold Kit used by a healthcare professional to make the SmartByte device and an optional SmartByte Reader component that connects to a mobile application wirelessly via Bluetooth to allow usage data to be uploaded to assess frequency of device usage, i.e., adherence and patient reported weight management.

The SMART Device is intended to aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) in the range 27-35 kg/m2 in conjunction with behavioral modification instruction.

The SMART Device is an oral removable palatal space occupying device that includes an embedded temperature recording sensor. The device is intended to be worn only during meals. to limit bite size and slow the intake of food, thereby reducing the amount of food that is consumed. The SMART Device is available using wire clasps and using a wraparound method (the wraparound technique is an added alternative to accommodate different oral anatomies) where the wires are coated with acrylic and wrapped around teeth in a symmetrical manner to secure the fit of the device (see Figure 1, below). The device is then removed after each meal or snack and the patient or healthcare professional has the option to use the temperature recording sensor embedded in the device to monitor device usage. This component of the SMART Device automatically records adherence, eliminating manual record-keeping by the user. The sensor is operated by a 3 volt lithium coin battery and measures ambient temperature at 5 minute intervals, storing the time and temperature data. The battery and the sensor are both double-encased and hermetically sealed in the acrylic. The SMART Device is provided with the Palatal Mold Kit and SMART Reader components. The Palatal Mold Kit is used to fabricate the SMART Device to match the patient's oral anatomy. The device is made from a mold of the upper oral cavity of the patient taken by a trained healthcare provider using the Palatal Mold Kit. The SMART Reader (See Figure 2, below) is an optional component that connects the sensor to a computer. Usage data are uploaded using infrared data transfer and a record of use can be produced. The user is provided instructions to download software for communicating between a personal computer and the SMART Reader and for displaying the time of day that the SMART Device was used. This software allows information from the embedded sensor to be uploaded to a secure, password protected Patient Portal website. Use of the Patient Portal allows the patient or healthcare provider to assess frequency of device usage.