Industry Watch

 Published: August 25, 2021

By: Debbie Bunch


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FDA Approves New Indication for Sleep Treatment

Xywav received FDA approval for a new indication. The drug had already been approved to treat excessive daytime sleepiness in patients with narcolepsy, age seven years or older. The new indication includes the treatment of idiopathic hypersomnia in adults. This condition causes people to be sleepy during the day even when they have gotten a good night’s sleep. Xywav is an oral solution consisting of calcium, magnesium, potassium, and sodium oxybates. “Idiopathic hypersomnia is a lifelong condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” said Eric Bastings, MD, deputy director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. Read More 

Red Tide Respiratory Forecast Now Considered Operational

The Red Tide Respiratory Forecast was developed by the National Centers for Coastal Ocean Science of the National Oceanic and Atmospheric Administration and others to predict the movement and harmful impact of algal blooms in the Gulf of Mexico. It has been moved from “experimental” to “operational.” The move means using the Forecast will now predict these blooms at the beach level. “We’ve been able to refine our forecasts and offer predictions on a beach-by-beach basis,” said Dr. Richard Stumpf, the oceanographer who led the Forecast development team. “This Forecast is the first step toward reducing the health and economic impacts of red tides for coastal communities. By letting people know where and when onshore respiratory impacts are expected, red tide becomes more of an inconvenience than a crisis.” Read More 


Single-Use Bronchoscope Receives FDA Clearance

According to Boston Scientific Corporation, the FDA has issued 510(K) clearance for the EXALT Model B Single-Use Bronchoscope. The device is designed for secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement, and biopsies performed in the ICU or operating room. “To effectively diagnose and treat disorders in the lungs and air passages, physicians require devices that provide high-quality imaging and visualization into a patient’s anatomy,” said Carla R. Lamb, MD, director of interventional pulmonary medicine and the Interventional Pulmonary Fellowship Program at Lahey Hospital & Medical Center. “In my view, this device represents a scientific advancement in single-use bronchoscopes which could improve patient care.” The EXALT comes in three sizes — slim, regular, and large — to provide superior suction performance and direct, precise imaging. Read More 

Stem Cell Treatment for COVID-19 Nearing EUA Filing

Therapeutic Solutions International, Inc., is preparing to file for Emergency Use Authorization for its JadiCells stem cell treatment for COVID-19-related lung injury. The treatment, which demonstrated superior activity when compared with other stem cell treatments in previous trials, was shown to be 100% effective in saving the lives of COVID-19 ICU patients under the age of 85 in an FDA clinical trial. The FDA granted clearance for a Phase III trial using the treatment for people with COVID-19 last June. “Given the urgent nature of the ongoing pandemic, and the early suggestions that our cells are effective against the delta variant, we are exploring and pursuing all possible avenues to bring JadiCells to the patients that need them now,” said Timothy Dixon, company president and CEO. Read More 

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Debbie Bunch

Debbie Bunch is an AARC contributor who writes feature articles, news stories, and other content for Newsroom, the AARC website, and associated emailed newsletters. In her spare time, she enjoys reading, traveling, photography, and spending time with her children and grandchildren. Connect with Debbie by email or on AARConnect or LinkedIn.

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