Raydiant Oximetry Secures FDA Approval for Lumerah Investigational Device Exemption (IDE) Study
“Each year 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” says Raydiant Oximetry founder and CEO, Dr. Neil P. Ray.
- “Each year 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” says Raydiant Oximetry founder and CEO, Dr. Neil P. Ray.
- Lumerah has received FDA Breakthrough Device Designation for expedited market approval.
- Completion of the EFS study will pave the path towards FDA IDE approval for a subsequent pivotal study.
- Raydiant Oximetry is supported by leading organizations that include the March of Dimes and the National Institutes of Health (NIH).