A force-based human machine interface to drive a motorized upper limb exoskeleton. a pilot study.

Muscular dystrophy is a strongly invalidating disease that causes the progressive loss of motor skills. The use of assistive devices, especially those in support of the upper limb, can increase the ability to perform daily-life activities and foster a partial recovery of the lost motor functionalities. However, for the use of these devices to be truly effective and accepted by patients, their activation must coincide with the user's intention to move. This work describes a new human-machine interface based on the integration of a six-axis force sensor to drive an upper limb motorized exoskeleton. This novel system can detect the patient's intention to move and produce displacements of the robotic device that are of magnitude and direction consistent with the user's wishes. The integration of the force-sensor interface in the BRIDGE/EMPATIA exoskeletal system was successful, and tests performed on both healthy and dystrophic subjects showed promising results, especially for the execution of planar movements.

Regulatory challenges of on-line hemodiafiltration.

The launch of on-line hemodiafiltration happened at a very peculiar time from the regulatory standpoint. The directives on medical devices were at their very beginning and the medicinal products regulatory regime was considering, after 30 years of operation of Directive 65/65/EEC, whether it was the case to go for greater harmonization. The success in the introduction of the therapy was strictly linked to the possibility of having the entire system approved for the European market according a single procedure. I had the pleasure to be part of the team, which included Dr. Wolfgang Kümmerle and my old friend Dr. Emanuele Gatti, which succeeded in gathering consensus on the classification of the on-line hemodiafiltration system as a medical device.