SIME AI device that predicts acute respiratory disease receives CE Mark - changing the standard of care for millions of babies worldwide - Yahoo Finance

2 years ago 36

The point-of-care device, which predicts terrible lung illness successful the ICU and NICU, has been CE marked for investigational use

, /PRNewswire/ -- SIME Diagnostics, a pioneer successful point-of-care respiratory diagnostics successful the ICU, contiguous announced the palmy CE-IVD accreditation of the world's archetypal Clinical AI Platform for the accelerated prediction of terrible respiratory disease. The CE marked instrumentality is designed for usage by clinicians, and measures routinely collected samples successful <15 minutes via a reagent-free disposable. The thousands of unsocial datapoints generated by the instrumentality are analysed by the platform's proprietary algorithms to present instantaneous results successful beingness captious situations erstwhile each 2nd counts.

The institution is present starting a aviator of 'RDS Predict', the archetypal of respective applications that volition soon beryllium disposable connected the platform. RDS Predict identifies which new-borns are apt to make Respiratory Distress Syndrome (RDS), the starring origin of morbidity and mortality successful premature babies. By predicting RDS astatine birth, neonatologists volition beryllium capable to present aboriginal and preventative targeted attraction wrong the archetypal hr of beingness - improving outcomes and redeeming lives. This caller screening trial is acceptable to alteration the modular of attraction for the 15 cardinal premature babies calved each year. Pilot sites person been selected from the apical NICU's successful Denmark, the UK and the US and a Clinical AI Platform instrumentality volition beryllium installed astatine each tract for investigational use. The real-world information generated volition some enactment an FDA submission and hole the institution for marketplace introduction successful 2023.

"The CE Mark is an important milestone for SIME arsenic it demonstrates the efficacy and information of a overmuch needed instrumentality successful acute respiratory care, arsenic good arsenic facilitating the adoption of our Clinical AI Platform successful the European market." said institution CEO Povl Verder. "Although some our Platform and RDS Predict person been validated successful aggregate peer-reviewed objective trials, this volition beryllium the company's archetypal merchandise aviator successful a real-world setting. This pilot, which volition beryllium led by neonatal cardinal sentiment leaders, volition further validate the life-saving imaginable of RDS Predict whilst generating thousands of caller information sets. This information volition beryllium utilized to accelerate the improvement of caller applications successful our merchandise pipeline."

SIME Diagnostics
SIME are shaping a aboriginal without acute respiratory disease. Our patented platform consists of a compact unreality connected instrumentality and reagent-free disposable designed for point-of-care usage successful intensive attraction units. Enabling the prediction of acute respiratory diseases wrong 15 minutes from routinely collected samples. The archetypal merchandise to marketplace is simply a accelerated trial for neonatal lung maturity (respiratory distress syndrome). Alongside powering predictive diagnostics, the company's Clinical AI Platform besides generates millions of unsocial datapoints - which are analysed by proprietary AI to thrust accelerated merchandise improvement and present caller illness insights.

Contact:
Morgaine Matthews
media@simedx.com