SoundHealth, a medical tech company, has introduced the groundbreaking Sonu, the first FDA De Novo-authorized AI-enabled wearable device specifically designed to treat moderate to severe nasal congestion caused by allergic and non-allergic rhinitis in individuals aged 22 and older. This novel, non-pharmaceutical option offers patients and clinicians a new avenue for managing nasal congestion, setting a new standard in medical treatment. The FDA’s classification of Sonu under the De Novo category highlights its innovative nature and promises a significant shift in the treatment landscape.Dr. Paramesh Gopi, CEO of SoundHealth, emphasized the potential of Sonu in delivering personalized relief from nasal congestion through the use of acoustic vibrational energy. This technology leverages the principles of humming, which can alleviate congestion by influencing autonomic inputs to the nasal mucosa or through the activity of nitric oxide, potentially reducing inflammation and providing a decongestant effect. Sonu’s approach stands out for its quick and drug-free relief mechanisms, addressing both consumer and investor interest in high-efficacy treatments that avoid the side effects commonly associated with pharmaceuticals.Following the product launch, SoundHealth has secured $7 million in seed funding, with significant contributions from Moai Capital and J4 Ventures, supplemented by investments from entities such as TeleSoft Partners, Tau Ventures, TechU Ventures, and Rhythm Venture Capital. This strong financial backing underscores the confidence of the investment community in Sonu’s potential and will be instrumental in driving its commercialization. With Peter Moran, a notable early-stage investor in digital health, joining SoundHealth’s board, the company is well-positioned to navigate the competitive medical tech industry effectively.
Expanding Horizons for a New Technology
SoundHealth, a medical tech innovator, has launched Sonu, the first FDA De Novo-authorized AI-enabled wearable device aimed at treating moderate to severe nasal congestion in adults aged 22 and older. This groundbreaking, drug-free solution offers a fresh approach to managing nasal congestion caused by both allergic and non-allergic rhinitis. The FDA’s De Novo classification underscores the device’s innovative character, marking a pivotal development in medical treatment.Dr. Paramesh Gopi, CEO of SoundHealth, highlighted Sonu’s potential to deliver personalized congestion relief using acoustic vibrational energy. This technology employs the principles of humming, which can alleviate congestion by affecting autonomic inputs to the nasal mucosa or boosting nitric oxide activity. This method may reduce inflammation and provide a decongestant effect, offering quick, drug-free relief without the side effects typically associated with pharmaceuticals.SoundHealth has raised $7 million in seed funding, with major contributions from Moai Capital and J4 Ventures, and support from TeleSoft Partners, Tau Ventures, TechU Ventures, and Rhythm Venture Capital. This financial backing reflects strong investor confidence in Sonu’s potential and will aid its commercialization. With Peter Moran, a prominent early-stage digital health investor, joining SoundHealth’s board, the company is poised to succeed in the competitive medical tech industry.
