The FDA has recently given Baebies Inc. permission to market the company’s Seeker System for the screening of several rare disorders in newborns known as LSDs or Lysosomal Storage Disorders. Prior to this, there were no FDA-authorized devices for the screening of these disorders.
http://www.bizjournals.com/triangle/news/2017/02/03/durhams-baebies-incgets-fda-nod.html
