FDA sees promise in voice-based AI model for heart failure
Noah Labs, a medtech company with offices in Berlin and Boston, has secured the U.S. Food and Drug Administration’s breakthrough device designation for its new voice-based algorithm for detecting signs of heart failure.
Noah Labs Vox was designed to provide remote monitoring for heart failure patients that evaluates five-second daily clips of the user’s voice. The company’s proprietary algorithm was trained with more than three million voice samples.
Noah Labs is currently preparing to launch a new clinical trial focused on the algorithm’s effectiveness. It has already been validated as part of partnerships with Mayo Clinic, the University of California, San Francisco, Charité Berlin, and other facilities all over the world.
“Voice is a powerful predictor for worsening heart failure,” Oliver Piepenstock, CEO and co-founder of Noah Labs, said in a company statement. “This breakthrough device designation is a pivotal milestone in Noah Labs Vox’s path to driving early access to life-saving interventions for patients with life-threatening diseases.”
“Early detection of clinical worsening is a central challenge in managing these patients—the ability to identify deterioration weeks before hospitalization, using nothing more than a patient's voice, has the potential to fundamentally change how we intervene and prevent adverse outcomes,” added Felix Hohendanner, MD, PhD, an assistant professor at Charité Berlin.
The breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. FDA representatives work directly with the manufacturer, for example, and all submissions are prioritized.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.