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, today announced U.S. Food and Drug Administration (“FDA”) 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. This allows the company to deliver on its mission to transform the mobility and quality of life of tube feeders. “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” said 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 US will commence in the coming weeks, with a full launch anticipated in Q1 2023.
About Rockfield Medical Devices Limited
Rockfield Medical Devices Limited, a company based in Galway, Ireland, is a commercial-stage medical device company focused on developing solutions to transform the mobility and quality of life of tube feeders. Rockfield Medical Devices is developing a portfolio of innovative feeding solutions for tube feeders. The company’s first product to market is the Mobility+ Enteral Feeding System, which has been 510(k) – cleared by the FDA for an Indication of Use to deliver liquid nutrition formula, to an enteral access device (feeding tube) in users aged 2 years and over.
