US Lawmakers Reintroduce Bill To Better Patient Access To Prosthetic Devices, Other Limb-Loss Technologies
The bipartisan Triple A Study Act directs the Government Accountability Office to report back to Congress on the coverage of assistive technologies for people with limb loss or limb difference.
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The Illinois senator pointed to an apparent mismatch between ongoing reports of equipment shortages, and alleged stockpiles of unsold masks.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
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.