FDA Clears First “Non-Significant Risk” Medical Device for Weight Management
Atlanta--Scientific Intake, a company dedicated to developing new products for overweight and obese consumers, announced today that the U.S. Food and Drug Administration (FDA) has cleared SmartByte® for use as an aid in weight management in overweight to obese individuals. The device is indicated for individuals with a body mass index (BMI) of 27 to 35 in conjunction with behavioral modification instruction.
Scientific Intake’s patented SmartByte is the first non-significant risk medical device of its kind that FDA has cleared for weight management in the overweight and obese population.
SmartByte is designed to occupy space in the roof of the mouth. It is made for each individual based on his or her oral anatomy, and is inserted by the user during meals and snacks, or while drinking caloric drinks. It works by decreasing the capacity of the mouth. The device slows intake by limiting bite size and increasing oral processing allowing users to feel satisfied on less food.
Each SmartByte contains an embedded sensor that automatically records usage every five minutes for up to 14 months. Proprietary software calculates adherence and progress to weight goals with easy-to-understand graphic displays.
Every clinical trial conducted with SmartByte demonstrated that use of the product resulted in better weight management.
Scientific Intake CEO William Longley said: “SmartByte replaces willpower. While the product itself is intuitive and easy to use, we studied SmartByte carefully in several controlled clinical trials. The evidence is clear: it works. Being hungry all the time and not being able to eat the foods they like are often cited as reasons why people fail to achieve their goals. SmartByte is designed to help address those issues by changing how you eat, not what.”
Mr. Longley added: “We all know eating slowly is beneficial, and a large body of science confirms it, but it is hard for people to change behavior. Our device is designed to help ingrain the new behavior and our sensor accurately provides feedback on adherence and progress. With multiple published clinical studies and now FDA clearance, this product will soon be available for the intended patient population. SmartByte provides a weight management option for patients without requiring surgery or implanting devices.”
Scientific Intake’s Chief Medical Officer Donna Ryan MD FACP, past President of the Obesity Society and President of The World Obesity Federation, has been involved with Scientific Intake since her tenure at the Pennington Biomedical Research Center, where the first feasibility study on SmartByte™ determined that users reduced their food intake by 23% to feel satisfied, compared to a control group without the device.
Dr. Ryan said, “SmartByte is an important new tool in our toolbox that can be widely used with confidence. At last we have an FDA-cleared device that can help people manage their weight – and clinical testing has demonstrated a very strong and favorable safety profile. In addition, patients do not need to undergo surgery or multiple endoscopic procedures to use the device, unlike approved implanted weight loss devices. SmartByte can be used with any diet the patient chooses and in any situation.”