Improvita, Inc., a Madison-based company affiliated with Innovenn, Inc., that focuses on human factors testing, ethnographic field research, user interface testing, and user experience testing for medical devices, software as a medical device, and combination drug / medical device products, is celebrating the approval of Beyond Air’s LungFit® PH by the U.S. Food and Drug Administration (FDA). The LungFit® PH has been approved to treat term and near-term neonates with hypoxic respiratory failure (prescription use only).
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Improvita and Beyond Air began their collaboration in 2021 to support the conduct of a human factors program, which resulted in the successful completion of the Human Factors Validation of the LungFit® PH. Improvita provided full service human factors testing, including protocol writing, risk assessment, task analysis, participant recruitment, study execution, data analysis, and reporting of study results. In addition, Improvita provided support for the regulatory negotiations with the FDA. This cross-company collaboration led the team to successful performance of the FDA required Human Factor’s validation. The testing was synchronize with Beyond Air’s business initiatives and the final report was expedited and submitted to the FDA in the first half of 2022. The product received FDA approval on June 28, 2022.
Improvita is beyond thrilled for Beyond Air’s LungFit® PH approval so that this product may have a positive impact on care for term and near-term neonates.
Beyond Air, Inc. is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide (NO) through its revolutionary NO Generator and Delivery System, LungFit®, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases