![]() “Our VCP software is designed to tap into both inspiratory and expiratory muscle strength, without requiring lip strength, and with far less chance of inducing laryngospasm or coughing,” said Dr. Spirometers often induce bouts of coughing which, given the COVID-19 pandemic, has made it increasingly difficult to objectively measure respiratory function in-clinic. Lip weakness can prevent creation of a tight seal around the spirometer and some with ALS experience an involuntary slamming shut of their vocal cords when they exhale forcefully. People with ALS often have problems achieving valid measures on standard in-clinic or at-home spirometers. As a result, regular assessment of respiratory function is the standard of care. Respiratory failure is the leading cause of death in patients with ALS. More about the Aural Analytics VCP™ Software in ALS “We continue to work closely with regulators at the FDA and key stakeholders across the healthcare industry to ensure safe, reliable, repeatable and transparent speech-based tools are brought to market.” This study will be the basis of multiple regulatory submissions for products that have broad clinical utility and commercial pathways,” said Daniel Jones, co-founder and CEO of Aural Analytics. “Aural Analytics is enabling clinical-grade speech analytics in areas of critical unmet patient and clinical need. Aural Analytics will also use the study to further demonstrate the safety and efficacy of its speech-based assessment software that enables on-demand, real-time objective monitoring of symptoms and progression in diseases known to impact bulbar function (speech and swallowing). The VCP™ software is currently being used as one approach to screen for eligibility in the Healey Center ALS platform trial at Massachusetts General Hospital. These measurements are commonly used in the assessment of airflow obstruction (COPD, asthma) and restrictive lung disease (ALS). The Aural Analytics VCP™ software tool enables on-demand, real-time objective evaluation of pulmonary function by predicting forced vital capacity (FVC) and forced expiratory volume (FEV1) without the need for specialized hardware in-clinic and at-home. The study, conducted as part of the Target ALS Diagnosis Initiative, is one of several pivotal studies Aural Analytics is set to kick off in 2021 as it expands its suite of clinical-grade speech-based digital tools. Food and Drug Administration (FDA) in late 2021. The company anticipates submitting the results of this multi-site, multi-language, 280 participant, prospective, blinded study to the U.S. SCOTTSDALE, Ariz.-( BUSINESS WIRE)- Aural Analytics, Inc., the industry leader in speech neuroscience and speech analytics technologies, announced today the initiation of a multi-product pivotal study to demonstrate the safety and efficacy of its speech-based tools for measuring pulmonary function and speech motor function in amyotrophic lateral sclerosis (ALS).
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |