DUBLIN, December 10 /PRNewswire/ --
- Software Addresses Important Unmet Need in Clinical Trials Using Echocardiography
ICON plc (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that its Medical Imaging division has launched a new cardiac echocardiography analysis software solution. The software, MIRA-ECHO, enables cardiac echocardiography (ECHO) images to be viewed, measured and interpreted in clinical trials and is the latest addition to ICON Medical Imaging's proprietary MIRA(TM) (Medical Imaging Review and Analysis) platform.
Dr. Jonathan Goldman MD, Chief Medical Officer at ICON Medical Imaging, and a recognised expert in echocardiography commented: MIRA-ECHO satisfies an important unmet need in clinical trials that involve ECHO. For the first time we have a solution that allows us to adjust and fine-tune traced cardiac measurements stored in the eCRF against a moving source image, whilst maintaining regulatory compliance and an audit trail. Combining MIRA-ECHO to the existing MIRA-QCA module for quantitative coronary angiography allows us to offer clients unparalleled capabilities for cardiovascular assessments.
ECHO is a widely used clinical method for assessment of heart structure and function. It is playing an increasingly important role in clinical trials as both a marker of cardiac safety and as a measurement of the therapeutic effects of drugs and devices being evaluated in patients with heart failure. Currently available ECHO software is limited by the inability of the interpreting physician to fine-tune tracings of measurements of the borders of the heart wall against the full motion image of the heart. This fine-tuning can optimise the accuracy of an important marker of heart performance - the left ventricular ejection fraction.
MIRA-ECHO is a digital DICOM (Digital Imaging and Communications in Medicine) image viewer and analysis software module that is integrated with an eCRF (Electronic Case Report Form). It displays links from the traced images back to the measured moving heart image, and also to the numerical measurements captured in the eCRF. Functionality embedded within the eCRF allows a physician to adjust preliminary measurements, while maintaining compliance with 21 CFR Part 11 regulations. MIRA-ECHO also enables measurement and assessment of the full complement of ECHO parameters.
About ICON Medical Imaging
Located in Warrington, PA, ICON Medical Imaging, a division of ICON plc, is the leading provider of Medical Imaging core laboratory services to pharmaceutical, biotech and life science clients globally. The team's extensive experience and expert guidance enables clients to maximise the success of their medical imaging endpoints, supporting their current research and development capabilities. ICON Medical Imaging has managed over 260 imaging trials in oncology, cardiovascular, CNS, medical devices and imaging agents.
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