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.
Asalyxa Bio Inc. has closed on an oversubscribed seed financing of more than $2 million designed to advance its lead candidate, ASX-100, into the clinic in acute respiratory distress syndrome.