SIME Acute Respiratory Disease Prediction Device Receives CE-IVD Accreditation

November 14, 2022

SIME Diagnostics has announced that its artificial intelligence-based (AI) clinical platform to predict severe respiratory disease has received CE-IVD accreditation. The device will use regularly collected samples to identify neonates that are at high risk for Respiratory Distress Syndrome (RDS) in an upcoming clinical trial.

According to Yahoo, “By predicting RDS at birth, neonatologists will be able to deliver early and preventative targeted treatment within the first hour of life – improving outcomes and saving lives. This novel screening test is set to change the standard of care for the 15 million premature babies born every year. Pilot sites have been selected from the top NICU’s in Denmark, the UK and the US and a Clinical AI Platform device will be installed at each site for investigational use. The real-world data generated will both support an FDA submission and prepare the company for market entry in 2023.”

To read more, click here.

(Source: Yahoo, November 14th, 2022)

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