Breakthrough in Obesity Solutions: Fuzzle’s Non-Invasive Oral Device Begins FDA Review Process

Dover, DE, Oct. 14, 2025 (GLOBE NEWSWIRE) -- In a major step forward for obesity solutions, Fuzzle, a pioneering health technology company, announced today that its innovative oral device has officially entered the U.S. Food and Drug Administration (FDA) review process.

The company has submitted a 510(k) application seeking Class II medical device clearance for its patent-pending technology that addresses habitual and emotional eating through a unique behavioral approach.

A Fresh Approach to Weight Management That Targets Food Cues and Cravings

Fuzzle's device introduces an entirely new way to tackle weight management challenges. By creating separations in the mouth that prevent the tongue from contacting the teeth, the device is designed to interrupt sensory reinforcement pathways tied to cravings and non-essential eating. This innovative mechanism is intended to reduce the sensory amplification of food cues and help decrease the automatic responses that drive overeating and what many describe as "food noise."

Unlike traditional approaches that rely on medications or restrictive diets, Fuzzle provides a drug-free solution that works with the body's natural sensory systems. The technology is evaluated as a potential step therapy before GLP-1 medications and as a valuable after-care option for individuals who have already achieved results and want to sustain them while building healthier long-term habits.

"We're excited to reach this pivotal milestone," said Jordan Hidalgo, CMO at Fuzzle. "Submitting our device for FDA review brings us one step closer to potentially offering people a novel, non-invasive approach to weight management. For those seeking solutions beyond pharmaceutical interventions, this represents an exciting new direction in behavioral and sensory-based innovation."

Early Observations Indicate Encouraging Trends and Reduced Food Noise

Through the 510(k) pathway, Fuzzle aims to demonstrate that its device meets the safety and performance standards required for Class II medical devices. What distinguishes this technology is its focus on behavioral and physiological support rather than hormonal mechanisms, reflecting a design intended to encourage sustainable habit change through sensory pathway disruption.

Preliminary observations from early users have been encouraging, suggesting potential body weight reductions of up to 2 percent per month and a perceived decrease in food-related thoughts and cravings. By focusing on sensory pathway disruption that may influence eating behavior, Fuzzle aims to introduce a behavioral reset mechanism designed to support healthier food choices and long-term habit formation.

Comprehensive Support System Combines Technology with Human Connection

Beyond the device itself, Fuzzle provides an integrated weight management support system centered on human connection and accountability. Participants meet one-on-one with a health coach through weekly video or phone sessions to discuss progress and goal setting. Between sessions, users can message their assigned Fuzzle Registered Dietitian or health coach directly through the app for guidance and encouragement, ensuring personalized support throughout their program.

Meal plans are developed collaboratively with the dietitian and updated with AI assistance for ongoing personalization, ensuring each user receives support tailored to their unique needs and goals. This combination of innovative technology and personalized human support creates a powerful foundation for lasting change.

Anticipated FDA Decision Expected by Q1 2026

As the FDA conducts its comprehensive review of the device’s design, safety, and supporting data, Fuzzle is preparing for what could be a significant regulatory milestone. The company anticipates a potential clearance decision by the first quarter of 2026, following completion of its clinical performance testing and FDA review timelines, moving this innovative solution closer to availability for individuals seeking new, non-invasive approaches to weight management.

The FDA submission process represents more than a regulatory step for Fuzzle, it reflects the company’s ongoing commitment to scientific rigor and user safety. By meeting the standards required for Class II medical device clearance, Fuzzle aims to ensure its technology fulfills its intended purpose before it reaches the public.

Building Momentum Toward Widespread Accessibility

Looking beyond the regulatory review, Fuzzle is already laying the groundwork for broader accessibility. The company is exploring partnerships with insurance providers to establish potential coverage pathways and planning future pilot programs aimed at making this technology available to a wider population. This forward-thinking approach reflects Fuzzle’s belief that true innovation involves not only developing breakthrough solutions but also ensuring people have meaningful access to them.

As the prevalence of obesity continues to rise globally, both healthcare providers and individuals are seeking new approaches to address this critical public health challenge. Fuzzle represents a promising advancement at the intersection of technology and behavioral science, offering support for those who have not found success with conventional methods, prefer to avoid medications, or want a more natural way to manage their health.

Looking ahead, Fuzzle plans to expand its technology with features such as adherence-tracking AI and potential applications in oral wellness. These future developments reflect the company’s continued commitment to innovation, safety, and advancing behavioral health solutions within the weight management space.

For more information about Fuzzle's groundbreaking technology, the science behind this novel approach to obesity management, and the latest updates on regulatory progress, visit Fuzzle.com.

Media Contact:
Logan Lauk
VP of Operations
Email: Team@fuzzle.com
Website: Fuzzle.com

About Fuzzle
Fuzzle is a U.S based health technology company on a mission to revolutionize weight management through innovative, non-invasive solutions. The company's patent-pending oral device technology leverages behavioral science and sensory feedback disruption, combined with personalized dietitian support and AI-enhanced meal planning, to help people achieve sustainable results and embrace healthier eating habits, naturally and effectively.

Media Contact:
Logan Lauk
VP of Operations
Email: Team@fuzzle.com
Website: Fuzzle.com

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