FDA De Novo classification

Paige Prostate software identifying a suspicious area in a biopsy slide
Paige receives FDA De Novo clearance for AI to detect prostate cancer
By Mallory Hackett | 12:51 pm | September 22, 2021
Paige Prostate analyzes digitized biopsy slides and identifies areas that could be cancerous for the pathologist to review further.
Caregiver records child on smartphone using Cognoa's Canvas Dx diagnostic software
FDA greenlights Cognoa's tool to detect autism spectrum disorder in kids
By Mallory Hackett | 01:42 pm | June 03, 2021
Canvas Dx is indicated as an aid in the diagnosis of ASD in patients between the ages 18 months and 5 years old who are at risk of developmental delay.   
The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.
FDA grants De Novo classification to Fifth Eye's continuous hemodynamic status monitoring tool
By Mallory Hackett | 01:26 pm | March 02, 2021
The Analytic for Hemodynamic Instability tool can identify hemodynamic instability with 96% sensitivity and detects stable patients with 85% specificity.