Industry Watch

 Published: June 8, 2021

By: Debbie Bunch



FDA Updates Respirator Recommendations

The FDA now recommends that health care facilities transition away from using non-NIOSH-approved respirators, citing increased domestic supply of new NIOSH-approved respirators coming on the market. The FDA also recommends that facilities no longer use the decontamination and bioburden reduction systems they have been using during the pandemic to conserve respirators. The FDA sent letters to health care facilities and personnel detailing these new recommendations earlier this spring. Read More  

Readmission Risk Prediction Algorithm for COPD in the Works

A pharmacy researcher from the University at Buffalo has received a $962,000 award from the NHLBI to develop a real-time readmission risk prediction algorithm designed to lower hospital readmission rates for patients with COPD. The project will combine social information with clinical data to build predictive models integrated into patient-centric interventions and tested in clinical practices. The goal is to individualize treatment at the transition from hospital to home. “Each year, 7.8 million hospital-discharged patients are readmitted, costing the United States $17 billion,” said David Jacobs, PharmD, PhD. He continues to explain that they will apply “innovative informatic techniques to the development of risk prediction models for hospital readmissions that ultimately personalizes care management interventions.” Read More  


Generic ADVAIR DISKUS Clears First FDA Hurdle

According to the Lannett Company, Inc., the FDA has accepted the Fluticasone Propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg, and 500/50 mcg) Abbreviated New Drug Application (ANDA). Lannett applied on behalf of its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd. The FDA has set a goal date of January 31, 2022 for this priority original ANDA. “The FDA’s Acceptance of the ANDA submission of generic ADVAIR DISKUS brings us one step closer to providing asthma patients an affordable option for this critical medication,” said Lannett CEO Tim Crew. While the company expects more than one FDA review cycle for the product, they believe they have the expertise to bring it to market sometime in 2022. Read More  

Noninvasive Gas Exchange Analyzer Wins Award

The MediPines AGM100 from MedPines received the Silver Award for Testing and Diagnostic products in the 2021 Medical Design Excellence Awards program. The device, billed as the world’s first noninvasive gas exchange analyzer, can rapidly detect respiratory impairment caused by a range of respiratory conditions, including COPD and COVID-19. It has been cleared by the FDA and approved for COVID-19 Emergency Use in Canada. Measurements provided by the device include blood oxygen levels, Oxygen Deficit (A-a gradient), P/F ratio, and alveolar oxygen and carbon dioxide levels. The MediPines AGM100 was the only respiratory device in the testing and diagnostic product category in this year’s Medical Design Excellence Awards program. 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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