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Robotic Arm Inventor Says 18 Months ‘Too Long’ To Approve Novel Device

 
• By Sue Darcey

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.

Deka R&D Corp. President Dean Kamen says 18 months is too long for “innovative technology” like the Deka LUKE prosthetic arm – an artificial limb with fingers sensitive enough to pick up and move an egg – to go through FDA’s approval process for devices. The arm was commercially launched by Mobius Bionics LLC on July 8, but was initially OK'd as a class II device via the de novo pathway in May 2014. (Also see "FDA Approves Advanced Prosthetic Arm" - Medtech Insight, 9 May, 2014.)

He said the advanced capabilities and urgent need for the prosthetic arm by soldiers returning from the battlefield and for veterans from older wars who have had to rely on...

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