Securing FDA Approval For Novel OPRA Prosthetic Wasn’t A ‘Slam Dunk.’ Here’s How Start-Up Integrum Made It Through The PMA Maze

In this case study, experts at the law firm Hogan Lovells and device maker Integrum AB tell Medtech Insight about some hurdles the Swedish start-up jumped when trying to win premarket approval from the US FDA for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.