ATU iHub Client Company, Rockfield Medical Devices has reached a major regulatory milestone with CE Mark approval for its flagship Mobility+® Elastomeric Enteral Feeding System. The certification permits commercial distribution of the device throughout the European Union and other CE-recognising markets, significantly expanding the company’s access to international healthcare systems and patients. This achievement represents a key step in Rockfield’s long-term strategy to scale globally from its base in the west of Ireland.
Mobility+® is the world’s first elastomeric enteral feeding system specifically designed to improve patient mobility, comfort and independence. Unlike conventional enteral feeding systems that rely on electronic pumps and stationary setups, Mobility+® provides a silent, electricity-free wearable alternative. The system is designed to support active lifestyles and greater autonomy for individuals who require long-term or home-based nutritional support, helping reduce the practical and psychological burdens often associated with enteral feeding.
The CE Mark approval follows the company’s successful FDA Over-the-Counter clearance in the United States, further strengthening its international regulatory footprint across two major developed markets. Clinical and real-world use in the US has shown strong acceptance among patients, caregivers and clinicians, with reported improvements in feeding tolerance, ease of use and overall quality of life. These outcomes highlight the system’s potential to address long-standing unmet needs in enteral nutrition.
With European regulatory approval now secured, Rockfield is positioned to accelerate commercial rollout across the EU and additional global regions. The milestone marks the beginning of the next phase of growth for the company and underscores the strength of innovation emerging from the Galway medtech ecosystem. It also reinforces Rockfield’s mission to enhance independence, comfort and quality of life for people who rely on enteral feeding worldwide.
