NewStem Files FDA Pre-Submission and EMA IVDD for Revolutionary Life-Saving, Treatment-Changing Diagnostic Device
Bio-Platform NewStem Ltd today announced the filing of a pre-submission to the FDA for a De Novo Request and an in vitro diagnostic device (IVDD) for EMA for their NewStem Software Diagnostic Device. The announcement followed the company's graduation from Illumina's Accelerator 3rd funding cycle in March 2022.