The FDA has inaugurated a new program called the Innovation Pathway to usher breakthrough medical technology through their approval process on a fast track. The first technology to take advantage of this program is the so called DARPA arm. This technology breakthrough is a potential precursor to a wide new range of products requiring a man machine interface.
The FDA provided a brief overview of the Innovation Pathway as follows;
“The proposed Innovation Pathway program includes the following features:
• products would have to be truly pioneering technologies with the potential of revolutionizing patient care or health care delivery;
• selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment and regulatory review; and
• products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.”
The Darpa Arm already has a lot of press. Here are a few interesting videos. The arm is controlled by a brain implanted electrode array which provides the signals which are interpreted by a sophisticated translation program to activate the appropriate actuators in the arm. The macaque monkeys were initially trained in a virtual environment and then graduated to a real environment.