FDA Regulation of Neurological and Physical Medicine Devices: Access to Safe and Effective Neurotechnologies for All Americans.

The United States Food and Drug Administration (FDA) ensures that patients in the U.S. have access to safe and effective medical devices. The Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the nervous system. This article addresses how to navigate the FDA's regulatory landscape to successfully bring medical devices to patients.

Design and implementation of visual-haptic assistive control system for virtual rehabilitation exercise and teleoperation manipulation.

This paper describes the design and implementation of a control system that integrates visual and haptic information to give assistive force feedback through a haptic controller (Omni Phantom) to the user. A sensor-based assistive function and velocity scaling program provides force feedback that helps the user complete trajectory following exercises for rehabilitation purposes. This system also incorporates a PUMA robot for teleoperation, which implements a camera and a laser range finder, controlled in real time by a PC, were implemented into the system to help the user to define the intended path to the selected target. The real-time force feedback from the remote robot to the haptic controller is made possible by using effective multithreading programming strategies in the control system design and by novel sensor integration. The sensor-based assistant function concept applied to teleoperation as well as shared control enhances the motion range and manipulation capabilities of the users executing rehabilitation exercises such as trajectory following along a sensor-based defined path. The system is modularly designed to allow for integration of different master devices and sensors. Furthermore, because this real-time system is versatile the haptic component can be used separately from the telerobotic component; in other words, one can use the haptic device for rehabilitation purposes for cases in which assistance is needed to perform tasks (e.g., stroke rehab) and also for teleoperation with force feedback and sensor assistance in either supervisory or automatic modes.

Mechanical design of a shape memory alloy actuated prosthetic hand.

This paper presents the mechanical design for a new five fingered, twenty degree-of-freedom dexterous hand patterned after human anatomy and actuated by Shape Memory Alloy artificial muscles. Two experimental prototypes of a finger, one fabricated by traditional means and another fabricated by rapid prototyping techniques, are described and used to evaluate the design. An important aspect of the Rapid Prototype technique used here is that this multi-articulated hand will be fabricated in one step, without requiring assembly, while maintaining its desired mobility. The use of Shape Memory Alloy actuators combined with the rapid fabrication of the non-assembly type hand, reduce considerably its weight and fabrication time. Therefore, the focus of this paper is the mechanical design of a dexterous hand that combines Rapid Prototype techniques and smart actuators. The type of robotic hand described in this paper can be utilized for applications requiring low weight, compactness, and dexterity such as prosthetic devices, space and planetary exploration.