Introducing the SmartByte Weight Management System


Results You Can Trust to Live a Healthy Life

Clinically-Proven Safe & Effective ● FDA Cleared ● Prescribed by your Doctor

The First and Only FDA-Cleared, Personal Weight Management System

Life’s a Balancing Act

Life is good until you’re suddenly thrown off balance – you learn that your weight has seriously impacted your health. It’s time to make some changes but how? You know that diets, exercise and other weight loss treatments just won’t work with your busy schedule. You need a solution that you can trust to help manage your weight and find your healthy balance.

Introducing SmartByte, the first FDA-cleared, personal weight management system that’s clinically-proven to safely and easily help you manage your weight so you can live a healthy life.

A Clinically-Proven Solution

The SmartByte System seamlessly integrates proprietary medical technology, behavioral science and digital intelligence to help you safely and easily manage your weight so you can live a healthy life.

In FDA clinical studies, people who used SmartByte over 4 months lost:1

  • Used as directed (At least 1/3 of meals)
    • 4.4% of their total body weight
    • 38.1% of their excess body weight
    • 8.8 pounds (200-pound person)
  • Not used as directed (60% of population) plus those that did use as directed:
    • 1.7% of their total body weight
    • 14.6% of their excess body weight
    • 3.4 pounds (200-pound person)

The SmartByte Device only works if used and people who used SmartByte during more meals, lost more weight.

In another published clinical study, people ate 533 fewer calories per day by using SmartByte and it takes 3500 calories to burn 1 pound of fat2. It’s well known in medical literature that losing weight has a positive impact on improving health3.

Why Choose SmartByte?

  • Clinically-Proven Effective → FDA-cleared & prescribed by your doctor
  • Clinically-Proven Safe → Wearable device – No prescription drugs and no surgical procedures
  • Easy → Only use when you eat; Add diet & exercise to fit your lifestyle
  • Supportive → Personal coaching team to achieve & maintain your goals

The SmartByte FDA-Cleared Medical Device

A small, removable, custom-molded medical device that you comfortably place on the roof of your mouth, only when you eat.

The SmartByte Device is the only FDA-cleared wearable to help you lose weight.

The SmartByte Self-Management App

The SmartByte Self-Management App gives you a comprehensive view of your results via your mobile phone.

The “MY WEIGHT” tab enables you to quickly input & simply track your actual weight loss results versus your weight loss goal.

My Meals

The “MY MEALS” tab connects with a sensor in your SmartByte Device to automatically track and record your daily usage over time.


The “HELP” tab provides you with helpful reminders, key contacts and answers to your most common questions.

The SmartByte Mobile App is the only digital platform that integrates eating behavior with weight loss results in real-time.

The SmartByte Personal Coaching Program

You will be matched with one of our certified weight loss professionals such as a registered dietitian who will work with you over the next 52 weeks. With your personal coach, you’ll learn to maximize the benefits of the SmartByte System, adopt new healthy habits and achieve your weight & health goals.

Your personal coach will leverage proven scientific methodologies and evidence-based techniques to help you implement small modifications – “mini mods” – to your eating habits and diet that lead to lasting weight loss. Your coach will also promote consistent and correct use of your SmartByte Device while you learn the fundamentals of nourishment and portion control.

The program will be highly adaptive to your individual needs and preferences with real-time modification of your treatment plan based on detailed analysis of your lifestyle, habits and clinical results. Ongoing communication with your personal coach will include phone calls, text messaging and email – all customized to your preferences.

SmartByte Personal Coaching is the only behavioral modification program that leverages a medical device, app & coach to help improve both how you eat and what you eat.

[1] FDA, Department of Health & Human Services, SMART Device, Regulation Number: 21 CFR§ 876.5981, 2016.

[2] Walden H., et al., A new dental approach to reducing food intake. Obesity Research 2004; 12: 1773-1780.

[3] Moore, L., Weight loss in overweight adults and the long term risk of hypertension: The Framingham Study. Arch Intern Med. 2005; June 13; 165(11): 1298-303.

[4] McGee, T. L., Grima, M. T., Hewson, I. D., Jones, K. M., Duke, E. B. and Dixon, J. B. (2012), First Australian Experiences With an Oral Volume Restriction Device to Change Eating Behaviors and Assist With Weight Loss. Obesity, 20: 126–133.