FDA Approves Glucose Monitoring Device by Signos for Weight Loss Supervision and Management

FDA Authorizes First Weight Loss System Accessible to All Adults

Washington D.C. – In a landmark decision, the Food and Drug Management on Wednesday authorized the first-ever glucose monitoring system tailored for weight loss, developed by Startup Signos.This approval establishes a novel option for individuals seeking to manage their weight, moving beyond customary restrictions based on body Mass Index (BMI).

breaking Down Current Weight Loss Barriers

Existing weight loss treatments – including widely used medications like GLP-1 receptor agonists and surgical procedures – have historically been primarily accessible to patients diagnosed with obesity or meeting specific BMI criteria. Medications such as Novo NordiskS Wegovy and Eli Lilly’s Zepbound, while effective, can be challenging to obtain due to high costs, limited insurance coverage, and supply constraints. according to recent data from the National Institutes of Health, the average cost of GLP-1 medications can range from $900 to $1,400 per month.

Signos: A New Approach to Weight Management

Signos offers a different path, allowing any individual to purchase a membership and gain access to its system.The company leverages an artificial intelligence platform combined with a readily available continuous glucose monitor (CGM) manufactured by Dexcom. This combination delivers personalized, real-time data and actionable lifestyle recommendations aimed at effective weight management.

“This is a solution for everyone embarking on a weight loss journey, and eliminates the prerequisite of a specific weight threshold,” stated Sharam Fouladgar-Mercer, Co-Founder and CEO of Signos, during a tuesday interview preceding the official proclamation.”Whether an individual aims to lose five pounds or one hundred, we are prepared to support them at any stage.”

The Economic Impact of Obesity

The obesity epidemic continues to strain the U.S.healthcare system, incurring costs exceeding $170 billion annually, as per data released by the Centers for disease Control and Prevention.Government statistics reveal that approximately 74% of American adults are either overweight or obese. Signos hopes to substantially impact this trend, contributing to improved health outcomes nationwide.

Cost and Accessibility

Signos is currently offering three-month and six-month membership plans priced at $139 and $129, respectively. These packages include all necessary CGMs for the duration of the chosen plan. While currently not covered by insurance, these plans represent a more affordable option compared to the roughly $1,000 monthly cost associated with GLP-1 medications in the United States.Signos is actively engaging with insurance providers and employers to explore potential coverage options. The company anticipates expanded accessibility as interest in tackling weight gain continues to grow.

Integration with Existing Treatments

According to fouladgar-Mercer, the Signos system is designed to be used in conjunction with GLP-1 medications or bariatric surgery.Moreover, it can assist individuals in sustaining weight loss after discontinuing GLP-1 therapy.

How continuous Glucose Monitoring Works

CGMs are small sensors worn on the upper arm that continuously track glucose levels, traditionally used by individuals managing diabetes.This data is wirelessly transmitted to the Signos app, where users can also log their dietary intake and exercise patterns, providing the AI platform with thorough information for tailored recommendations. The goal extends beyond simply achieving weight loss; it’s about empowering users to understand their body’s responses to various foods and activities, enabling lasting behavioral changes.

While Signos has not publicly disclosed the number of current users, Fouladgar-Mercer indicated that tens of thousands have utilized the system to date. The company has scaled its inventory of CGMs and enhanced its software capabilities to accommodate anticipated increased demand.

The Future of Personalized Weight Management

The FDA’s approval of signos marks a significant shift towards personalized weight loss solutions.As technology continues to advance, we can expect to see more data-driven approaches that empower individuals to take control of their health. The emphasis is shifting from one-size-fits-all diets to customized plans based on individual metabolic responses.

Treatment Option	Typical Cost	Accessibility	Requirements
GLP-1 Medications (Wegovy, Zepbound)	$900 – $1,400/month	limited due to cost & supply	Obesity diagnosis or high BMI
Bariatric Surgery	$20,000 – $70,000 (one-time)	Requires medical evaluation	Severe obesity & specific health criteria
Signos System	$129 – $139/month	Open to all adults	Signos membership

Did You Know? According to the CDC, obesity rates in the U.S. have nearly doubled since 1990.

Pro Tip: Combining CGM data with a food journal can help you identify hidden triggers for blood sugar spikes, which can contribute to weight gain.

Frequently Asked Questions

• What is a CGM and how does it help with weight loss? A Continuous Glucose Monitor tracks your blood sugar levels in real-time, providing insights into how your body responds to different foods and activities.
• Is the Signos system covered by insurance? Currently, the Signos system is not typically covered by insurance, but the company is working to change that.
• Can I use Signos if I’m already taking GLP-1 medication? Yes, the Signos system can be used in conjunction with GLP-1 medications or bariatric surgery.
• How much does the Signos system cost? A three-month plan costs $139, and a six-month plan costs $129 per month.
• What kind of data does the Signos app collect? The app collects data on your food intake, exercise levels, and continuous glucose readings.

What are your thoughts on the potential of personalized data for weight management? Share your opinions in the comments below!

What specific data points, beyond glucose levels, does the Signos app collect adn analyze to provide personalized weight loss recommendations?

FDA Approves Signos Glucose monitoring Device for Weight Loss Supervision & Management

What is the Signos Device and Why the FDA Approval Matters?

The Food and Drug Management (FDA) recently granted approval for Signos, a continuous glucose monitoring (CGM) system, specifically for use in weight loss supervision and management. This isn’t just another fitness tracker; it’s a medical-grade device previously used primarily by individuals with diabetes, now cleared for a broader population aiming for healthier lifestyles. This approval signifies a shift towards personalized nutrition and a more data-driven approach to weight management. The core technology revolves around tracking real-time glucose levels, providing insights into how your body responds to different foods, exercise, and stress.

How Does Continuous Glucose Monitoring (CGM) Aid weight Loss?

Traditionally, weight loss focused heavily on calorie counting. While significant,this method frequently enough overlooks how those calories impact your body. A CGM like Signos reveals the individual metabolic response to food. Here’s how it works:

Personalized Insights: Instead of generic dietary advice, Signos identifies your unique glucose response to various foods. A food considered “healthy” might actually cause a significant glucose spike for you, hindering weight loss.

Metabolic Adaptability: The device helps assess your metabolic flexibility – your body’s ability to efficiently switch between burning carbs and fats for fuel. Poor metabolic flexibility is ofen linked to weight gain and insulin resistance.

Real-Time Feedback: Unlike customary methods, you receive immediate feedback on how your choices affect your glucose levels, allowing for instant adjustments. This promotes mindful eating and better food choices.

Beyond Calories: CGM data highlights the importance of glycemic load – the impact of food on blood sugar – rather than solely focusing on caloric intake. This is crucial for enduring weight management.

Signos Device Features & Functionality

The Signos system consists of a small sensor worn on the upper arm and a mobile app. Key features include:

Real-Time Glucose Data: continuous monitoring provides glucose readings every 15 minutes.

Personalized Food Scores: The app assigns scores to foods based on your individual glucose response.

Actionable Recommendations: Signos provides tailored recommendations for meal timing, food pairings, and exercise based on your data.

Trend analysis: The app tracks glucose trends over time, helping you identify patterns and make long-term lifestyle changes.

Integration with Other Apps: Signos integrates with popular fitness trackers and health apps for a holistic view of your health data.

Dedicated Support: Users have access to registered dietitians and health coaches for personalized guidance.

Understanding Glucose Spikes and Weight Management

Glucose spikes – rapid increases in blood sugar – are now understood to be detrimental to weight loss efforts. Frequent spikes can lead to:

1. Insulin Resistance: Over time, your body may become less responsive to insulin, leading to increased fat storage.
2. increased hunger: Glucose crashes often trigger cravings and overeating.
3. Inflammation: High glucose levels contribute to chronic inflammation, which is linked to various health problems, including obesity.
4. Reduced Energy Levels: Fluctuations in blood sugar can cause energy dips and fatigue.

Signos helps users minimize these spikes by identifying trigger foods and suggesting strategies to stabilize glucose levels. Strategies include pairing carbohydrates with protein and fat, choosing lower-glycemic index foods, and incorporating regular physical activity.

Who is Signos Best Suited For?

While the FDA approval broadens accessibility,Signos is particularly beneficial for:

Individuals Struggling with Weight Loss: Those who have tried traditional diets without success may find the personalized insights of Signos helpful.

People with Insulin Resistance or Prediabetes: Monitoring glucose levels can definitely help manage these conditions and prevent progression to type 2 diabetes.

Athletes & Fitness Enthusiasts: Optimizing glucose levels can enhance performance and recovery.

Individuals Seeking Personalized Nutrition: Signos provides a data-driven approach to understanding your body’s unique needs.

Those Interested in Metabolic Health: The device offers a comprehensive view of your metabolic function.

Cost and Accessibility of the Signos Device

The Signos system operates on a subscription model.As of late 2025, pricing typically includes an initial kit with the sensor and access to the app, followed by monthly subscriptions for ongoing sensor replacements and access to coaching services. The cost is generally higher than standard fitness trackers, reflecting the medical-grade technology and personalized support offered. Availability is currently direct-to-consumer through the Signos website (https://signos.com/).

Potential Side Effects and Considerations

While generally safe, using a CGM like Signos can have minor side effects:

Skin Irritation: Some individuals may experience mild irritation at the sensor insertion site.

* Accuracy Concerns: CGM readings are not always perfectly accurate and should not be used to make critical medical decisions without consulting a