“Over the next decade, medical technology innovations will fundamentally transform health care and delivery systems, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered.”

The FDA’s announcement in May of this year outlined its intentions to implement ground-breaking alterations in the way the FDA operates and to its place in the development of new treatments. In addition, as demonstrated in the quote above from its official web site, the FDA acknowledges that medical treatment is changing and development of medical devices is leading the way into a new era.

Rimon is part of what the FDA refers to as the “unfolding pattern of ‘smart’ technologies that integrate engineering and biological approaches” that enable “precise clinical interventions”. In the treatment of wound care, Rimon’s primary product, the MI-Sorb™dressing (now in clinical trials), is on the front line of this development. Rather than acting as a passive dressing, providing protection and absorption of exudates, the MI-Sorb™ dressing actively works to counter the damaging effect of matrix metalloproteinases (MMPs) produced by the body, and by doing so, allows for healing to occur.

As a Class I device, MI-Sorb™ operates with drug-like margins, but benefits from the shorter device timelines. The announcement by the FDA to implement changes intended to facilitates the movement of “smart” devices from research to market could further reduce the timeline for MI-Sorb™ to be introduced to patient care and the costs involved in doing so.