The FDA has granted de novo authorization to Fifth Eye Inc. for its Analytic for Hemodynamic Instability (AHI), a machine learning (ML)-based, real-time indicator of patient deterioration. Commercialization of the software device, which continuously monitors patients with an electrocardiogram (ECG) for signs of deterioration, got underway on March 1.
A new study by Mayo Clinic and Nference Inc. researchers suggests that prior childhood and adult vaccinations for illnesses such as polio, measles and flu may provide protection against COVID-19 infection. The study, which analyzed patient data using Nference artificial intelligence (AI) software, underscores the critical role immunizations play in curbing the spread of diseases and preventing future pandemics. “What we discovered represents compelling evidence that vaccinations are a critical element in prevention of disease, even diseases one doesn’t anticipate,” said Venky Soundararajan, co-founder and chief scientific officer of the Cambridge, Mass.-based company.
Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions.