SIME Diagnostics Respiratory Diagnostic AI Gains CE-IVD Mark
SIME Diagnostics has received the CE-IVD mark for its Clinical AI (artificial intelligence) Platform for rapid detection of severe respiratory disease.
Using routinely collected samples, the device analyzes thousands of datapoints to deliver results in under 15 minutes.
The company is starting a pilot study of its RDS Predict application to identify newborns likely to develop respiratory distress syndrome (RDS), a breathing problem that often occurs in premature babies. RDS Predict will be the first of several applications that will soon be available on the platform.
SIME Diagnostics intends to use real-world generated data to support an FDA submission and prepare for market entry in 2023.