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Capture.JPGCapture.JPGCDRH-Record Year for Device Innovation

Success in advancing device innovation and approval/clearance novel, safe and effective technologies

  • Approval of 106 novel devices, surpassing the 40-year record we set in 2017 of 99
  • Granted 112 Breakthrough Device Designation requests;  9 approved/cleared

Examples of innovative products

  • Automated insulin dosing system – including for those as young as age 7
  • World’s smallest heart valve for newborns
  • First blood test in the world to evaluate mild traumatic brain injury
  • First mobile medical app to help treat substance abuse disorders
  • Artificial Intelligence to detect diabetic retinopathy in adults
  • Artificial Intelligence to detect wrist fractures
  • First artificial iris


captureNew Drug Class Employs Novel Mechanism for Migraine Treatment and Prevention

Recently approved drug class targeting  calcitonin gene-related peptide (CGRP) – elevated in blood serum during migraine attacks

  • New migraine drugs block effects of CGRP
  • Specialized monoclonal antibodies cloned subclasses of immunoglobulin G (IgG)
  • Designed to have low potential to interact with other drugs
  • Metabolized differently with fewer adverse reactions
  • Aimovig (erenumab-aooe), Ajovy (fremanezumab-vfrm), Emgality (galcanezumab-gnlm)


Image credit: FDA