Neurovalens Granted FDA De Novo Approval for Modius Lean Weight Management Device
Summary
Neurovalens received FDA De Novo approval for Modius Lean, its non-invasive neurotechnology device for weight management. Modius Lean uses low-level electrical signals to non-invasively stimulate areas of the brain known to regulate metabolic health. The approval was supported by a pivotal clinical trial of 241 overweight and obese adults showing a 13 percent reduction in visceral fat over six months while preserving lean muscle mass. This is Neurovalens' third FDA-approved device, following Modius Sleep for insomnia and Modius Calm for anxiety.
Why it matters
This De Novo approval creates an entirely new FDA device category for non-invasive neurostimulation in weight management, representing a genuinely novel therapeutic approach to obesity. By targeting brain regions that regulate metabolism rather than relying on drugs or invasive procedures, Modius Lean offers a drug-free alternative at a time when three in four U.S. adults are considered overweight or have obesity.
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