Rockfield Medical Devices Limited, a commercial-stage medical device company focused on developing solutions to transform the mobility and quality of life of tube feeders, announced U.S. Food and Drug Administration 510(k) clearance of the Mobility+ Enteral Feeding System.
The Mobility+ Enteral Feeding System is a portable, lightweight, non-electronic, enteral feeding system that delivers liquid nutrition formula to an enteral access device (feeding tube) in users aged 2 years and over, in clinical or home care settings. The system has three primary components: a food pouch, filling set, and giving set. The System is for single patient use, intended for use over a 24-hour period.
This FDA clearance, for the first time, allows Rockfield Medical Devices to market the Mobility+ Enteral Feeding System in the United States.
“We are excited to bring this innovative technology to the United States and believe that it will uniquely and positively transform the quality of day-to-day life of enteral tube feeders” says Tomás Thompson CEO of Rockfield Medical Devices, himself a former tube feeder, whose recognition of the many limitations of current enteral feeding systems on the market, led to the design and development of the Mobility+ Enteral Feeding System.
Limited market release of the Mobility+ Enteral Feeding System in the United States will commence in the coming weeks, with a full launch anticipated in Q1 2023.