SAN FRANCISCO--(BUSINESS WIRE)--Jun 11, 2025--
SoundHealth, a medical technology company harnessing the power of artificial intelligence and medical science to improve patient outcomes, announced it received United States Food and Drug Administration (FDA) approval for pediatric use of its groundbreaking SONU Band. SONU is the world’s first FDA De Novo authorized, AI-enabled, wearable medical device for at-home treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. This expanded approval makes SONU the first FDA-approved, drug-free solution for nasal congestion and allergies in children ages 12 and up, providing a safe alternative to pharmaceutical treatments.
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“SONU offers a promising new option for children struggling with chronic nasal congestion. As a non-invasive, drug-free solution, it addresses a significant need among families looking for safe, effective alternatives to traditional therapies—particularly those involving steroids or medications with side effects,” said Dr. Alan Greene, Adjunct Professor of Pediatrics, Stanford University; Principal Investigator.
Clinically proven to be fast-acting and effective, over 80 percent of SONU patients reported improvement in their nasal symptoms. SONU represents a brand-new category of safe and rapid relief therapies for nasal congestion and spares patients from the side effects commonly associated with other treatment options.
“Nasal congestion and allergies don’t have to be life-altering,” said Dr. Paramesh Gopi, founder and CEO of SoundHealth. “Our team of scientists, engineers and medical professionals has truly revolutionized respiratory health with AI-powered sound therapy. We are thrilled to now be able to offer relief from congestion to children and will continue to work toward helping people breathe better.”
SONU is easy, convenient and pleasant to use for patients. Using SoundHealth’s proprietary AI technology, the SONU app scans the patient's face using a smartphone and creates a digital map of their sinuses, calculating their optimal resonant frequencies. Following the initial one-time scan, the patient simply places the SONU Band around their head, turns it on and the band delivers frequencies tailored to the patient based on the app’s calculations.
The science behind SONU:
SONU is the only FDA-approved device equivalent to or better than the leading nasal steroid spray, calming down symptoms of allergies, inflammation and congestion. For more information, please visit https://soundhealth.life/.
About SoundHealth
SoundHealth is a medical technology company that harnesses the power of artificial intelligence and medical science to improve respiratory and mental health. The SoundHealth team consists of experienced medical professionals, data scientists and engineers who are passionate about improving healthcare. Visit https://soundhealth.life.
SoundHealth has developed the world’s first FDA-approved, wearable device for children 12 and up that offers a drug-free, safe solution for treating nasal congestion and allergies.
RIO DE JANEIRO (AP) — Brazilian President Luiz Inácio Lula da Silva unveiled a pilot plan Friday to expand the federal government’s role in fighting organized crime in Rio de Janeiro, spotlighting a major voter concern in the lead-up to October’s presidential election.
The plan expands existing joint operations among federal, state and municipal authorities along Rio’s key highways and in selected territories, with a focus on increased shared intelligence, coordinated policing and inspections.
Sen. Flávio Bolsonaro, Lula’s main rival and son of ex-President Jair Bolsonaro, and U.S. President Donald Trump have accused Lula of insufficient action to curb organized crime groups that control large swaths of Rio and remote areas such as the Amazon.
“This is a new beginning to create a new template for public security in this country,” Lula said. “God wanted us to begin with Rio de Janeiro, because if it works in Rio, it will work across the country.”
Efforts include expanding coordinated policing, inspections, intelligence and surveillance along the state’s main logistics corridors to target cargo theft and weapons and drug trafficking, while also going after the financial networks of organized crime.
“Lots of people ask why Lula, who has been president three times, hasn’t already taken responsibility for public security,” Lula said. He said most of the public security has been in the hands of state governments since the 1988 Constitution, a mistake he said his government wishes to rectify.
Some observers say Lula’s government accelerated efforts to combat organized crime after Rio’s deadliest police operation last year, when more than 120 people were killed. Polls afterward showed an increase in then-Gov. Claudio Castro’s approval rating and strong support for the deadly raid.
In May, Lula launched a $2 billion anti-organized crime project that included beefing up the fight against arms trafficking, attacking the finances of criminal organizations, raising the quality of homicide investigations and investing in the country’s prison system.
On Friday, Lula again criticized Trump’s decision earlier this year to classify the First Command of the Capital, or PCC, and the Red Command, or CV, as foreign terrorist organizations, saying that while the groups terrorize local populations they are not terrorist organizations because they seek profit rather than political change.
Some analysts and politicians have said the classification of the PCC and CV is an attempt to meddle in Brazil's crucial election by making Lula look soft on crime.
Follow AP’s coverage of Latin America and the Caribbean at https://apnews.com/hub/latin-america
Brazilian President Luiz Inacio Lula da Silva, center, arrives for a ceremony to announce a new security plan to combat organized crimes in Rio de Janeiro, Friday, Sept. 18, 2026. (AP Photo/Silvia Izquierdo)
Brazilian President Luiz Inacio Lula da Silva poses for photos during a ceremony to announce a new security plan to combat organized crime in Rio de Janeiro, Friday, Sept. 18, 2026. (AP Photo/Silvia Izquierdo)
Brazilian President Luiz Inacio Lula da Silva, center, talks with the Rio de Janeiro's Gov. Ricardo Couto, right, and Brazil's Justice Minister Wellington Lima e Silva during a ceremony to announce a new security plan to combat organized crime in Rio de Janeiro, Friday, Sept. 18, 2026. (AP Photo/Silvia Izquierdo)
Brazilian President Luiz Inacio Lula da Silva speaks during a ceremony to announce a new security plan to combat organized crime in Rio de Janeiro, Friday, Sept. 18, 2026. (AP Photo/Silvia Izquierdo)
Brazilian President Luiz Inacio Lula da Silva arrives for a ceremony to announce a new security plan to combat organized crime in Rio de Janeiro, Friday, Sept. 18, 2026. (AP Photo/Silvia Izquierdo)
