Robotic arms are test case to speed FDA reviews
Molly Peterson, Bloomberg News
Wednesday, February 9, 2011
Robotic arms controlled by a microchip in a patient's brain will serve as a test case for a Food and Drug Administration plan to expedite development and regulatory reviews of new medical technologies.
The prosthetics were designed by the Defense Advanced Research Projects Agency, part of the Pentagon, to restore "near natural" arm, hand and finger function to amputees or patients who have suffered strokes or spinal-cord injuries, the FDA said Tuesday in a statement.
The device will be the first reviewed under an FDA initiative that intends to foster "truly pioneering technologies with the potential of revolutionizing patient care or health care delivery," the agency said. The FDA invited public comments and scheduled a March 15 public meeting on the proposed plan, known as the Innovation Pathway.
The move is part of a broader effort by the agency to spur innovation through more efficient medical-device reviews. Products that qualify for the Innovation Pathway program would be assigned an FDA case manager and get a plan and timeline for development and clinical assessment.
The robotic arm is ready to go, and the microchip may be set for clinical trials within six months, Geoffrey Ling, a program manager and a colonel in the U.S. Army, said at the briefing. The FDA's involvement will help the defense agency design trials and assess whether the device needs modifications, Ling said.
The FDA must "maintain its focus on bringing greater speed and consistency to the current review process and on addressing the full spectrum of concerns that have contributed to unacceptable delays" in device approvals, Stephen Ubl, CEO of the Advanced Medical Technology Association trade group of Washington, said in an e-mail.
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Christopher
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- Injury Description, Date, extent, surgical intervention etc: Date of Injury: 12/15/02
Level of Injury:
-dominant side C5, C6, & C7 avulsed. C8 & T1 stretched & crushed
BPI Related Surgeries:
-2 Intercostal nerves grafted to Biceps muscle,
-Free-Gracilis muscle transfer to Biceps Region innervated with 2 Intercostal nerves grafts.
-2 Sural nerves harvested from both Calves for nerve grafting.
-Partial Ulnar nerve grafted to Long Triceps.
-Uninjured C7 Hemi-Contralateral cross-over to Deltoid muscle.
-Wrist flexor tendon transfer to middle, ring, & pinky finger extensors.
Surgical medical facility:
Brachial Plexus Clinic at The Mayo Clinic, Rochester MN
(all surgeries successful)
"Do what you can, with what you have, where you are."
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