Robotic Arm Inventor Says 18 Months ‘Too Long’ To Approve Novel Device
Executive Summary
US FDA needs to speed up its approval procedures for review of revolutionary devices like the LUKE prosthetic arm, says its inventor Dean Kamen. The arm was launched by Mobius Bionics on July 8. Kamen took a few moments after testifying at a House robotics hearing to explain its capabilities to Medtech Insight and share his thoughts about the FDA device review process and the spirit behind the 21st Century Cures bill.
You may also be interested in...
FDA Formally Classifies Cardiac Surgery Device, Robotic Arm
Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.
Quest For Political Capital, Legacy Could Push 'Cures' Over The Finish Line
When Congress returns to work after the summer recess, the House and Senate medical innovation packages may gain momentum as legislators seek a “feather in the cap” for reelection campaigns, and House Energy and Commerce Committee Chair Fred Upton and Vice President Joe Biden look to cement legacies, say legislative analysts. Also, a Zika virus funding rider is expected be attached to a continuing resolution.
Final Guidance Encourages Use Of Patient Preference In Device Applications
US FDA released a final guidance aimed at helping sponsors and other stakeholders interested in using patient-preference information to make their case for a device application. The agency has decided to keep its labeling recommendation in the final guidance despite industry objections.