All articles tagged with #fda breakthrough device
A new AI-based software developed at WashU Medicine, called Prognosia Breast, has received FDA Breakthrough Device designation for its ability to analyze mammograms and provide a more accurate five-year breast cancer risk prediction, potentially improving early detection and prevention efforts.
Cordio Medical's HearO app, designated as an FDA Breakthrough Device, uses artificial intelligence to detect signs of congestive heart failure (CHF) by monitoring a person's voice, alerting doctors of imminent risks before symptoms appear. In trials, the app successfully predicted heart failure in 81% of cases, about three weeks before it occurred, potentially reducing hospitalizations and improving patient outcomes. Cordio plans to expand the technology to detect other conditions and has partnered with AstraZeneca for pilot programs in the US and Europe. FDA approval for the CHF indication is forecast for Q1 2025, with CE certification already obtained in the EU.