Paige, a digital pathology diagnostics company, has received De Novo marketing authorization from the Food and Drug Administration for its artificial intelligence software that helps detect prostate cancer.
The Paige Prostate software analyzes digitized biopsy slides and identifies areas that could be cancerous for the pathologist to review further.
“The approval is a landmark achievement in the...
Pediatric behavioral health company Cognoa has received FDA De Novo classification for its autism spectrum disorder (ASD) software diagnostic aid, Canvas Dx.
The ASD diagnostic tool is designed to help primary care clinicians and pediatricians evaluate and diagnose suspected cases of autism among children. It uses machine learning algorithms to analyze videos of the child’s behavior and responses...
Fifth Eye, a Michigan-based real-time clinical analytics company, announced today that the Food and Drug Administration has granted De Novo classification for its Analytic for Hemodynamic Instability (AHI) tool.
The technology links with hospitals' existing electrocardiograms to create a reading of patients' hemodynamic status every two minutes. Once AHI completes a reading, it uses machine...
