The Scientific Intake website is not intended for a U.S. audience. The website describes our product, Sensor Monitored Alimentary Restriction Therapy (SmartByte™). The product has not been cleared for marketing by the Food and Drug Administration and is not available for sale in the U.S.
SmartByte™ is limited by U.S. law to investigational use only. It has been designated Non Significant Risk by the FDA.
Outside the U.S., Scientific Intake's SmartByte™ is designated a Class I medical device and has been granted the CE Mark (Europe), and has been approved by Health Canada, Anvisa ( Brazil) and TGA (Australia).
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