NECDetect for preterm babies has been authorized as a Breakthrough Device by FDA
Chosen Diagnostics is pleased to announce that the US Food & Drug Administration has granted NECDetect, and its proposed indication of use, the designation of a 'Breakthrough Device.' Authorized devices are technological breakthroughs and offer significant improvement compared to current alternatives. The Breakthrough Device program will help patients receive more timely access to these medical devices by expediting their development, assessment and review by the FDA.
Chosen Diagnostics receives NSF award for kit reference standard development
The National Science Foundation (NSF) has awarded Chosen Diagnostics a $225K Small Business Innovation Research (SBIR) grant. The non-dilutive funding supports optimization of detection method and accurate reference standards that take into account age and race. "NSF is proud to support the technology of the future of thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering," said Andrea Belz, Division Director of the Division of Industrial Innovation and Partnerships at NSF.
Chosen Diagnostics receives NICHD award to develop diagnostic test
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health has awarded Chosen Diagnostics a $330K Small Business Technology Transfer Research (STTR) award. The project will focus on the development of a diagnostic biomarker for necrotizing enterocolitis (NEC). NEC is the most common gut inflammatory emergency in preterm infants and is often fatal. As a consequence of limited and poor diagnostic methods available to clinicians, NEC healthcare is the US requires $3 billion annually.