Neurovalens wins FDA nod for weight management neurostim device

Neurovalens announced that it received FDA de novo approval for Modius Lean, its non-invasive neurotechnology for weight management.

Belfast, Northern Ireland-based Neurovalens designed its Modius technology to use low-level electrical signals to non-invasively stimulate areas of the brain known to regulate key functions, such as the management of sleep, anxiety and overall metabolic health. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes.

The company also picked up an FDA nod for its Modius Sleep device for treating insomnia in October 2023 and launched it last year. It then received FDA clearance for Modius Calm for anxiety in April 2024, The company has also raised approximately £20 million (nearly $27 million) to date, including $8.1 million earlier this year.

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