The Preventive Care Gap in the US and a UK App Built to Fill It
Why the US Needs Better Preventive Care Tools
The United States spends more on healthcare than any other country, yet much of that spending goes toward treating advanced disease rather than preventing it. Care is often episodic, fragmented, and reactive, with limited visibility into how patients are doing between visits. This gap has real consequences, especially for chronic conditions that could be managed earlier with better data and clinical oversight. Remote patient monitoring is emerging as one of the clearest opportunities to shift care from reaction to prevention.
How Emerald Is Already Solving This Problem in the UK
Presented in December 2025 at the Giant Health conference in London, Emerald is a UK-based digital health platform designed to make preventive care more actionable. It addresses the problem of fragmented health data by bringing together information from sources such as blood tests and wearable devices and presenting it in a longitudinal, easy-to-understand view. Rather than replacing clinicians, the platform supports users with insights focused on early risk awareness and connects them with general practitioners when medical guidance is needed. This prevention-first approach aligns well with the NHS, which emphasizes population health, continuity of care, and early intervention.
Emerald’s Opportunity in the American Healthcare System
American healthcare generates vast amounts of patient data, but much of it is underused and disconnected from day-to-day clinical decision-making. Patients collect wearable data at home, labs generate results in separate systems, and clinicians often see only a partial snapshot during short, infrequent visits. As a result, early signs of deterioration are missed, care becomes reactive rather than preventive, and clinicians spend time chasing information instead of managing patients. A tool like Emerald could help bridge the gap between continuous patient data and episodic clinical care in the US healthcare system.
A Practical FDA Strategy for Emerald
A successful US entry would begin with clearly defining Emerald’s intended use for the FDA. A strong first step would be positioning the platform as software that aggregates and analyzes patient health data to support remote patient monitoring under clinician supervision. With this framing, the product would likely fall under Class II risk and be eligible for the 510(k) pathway. The next step would be identifying an appropriate predicate among existing FDA-cleared RPM platforms with similar data aggregation and clinician review functions, such as devices approved under product code DRG, which covers software-based tools for remote patient monitoring. This approach prioritizes speed, predictability, and a focused first clearance.
Why US Expansion Is Achievable and Worth It
Emerald already demonstrates that preventive, data-driven care can work at scale. With thoughtful regulatory framing and guidance, entering the US market does not require reinventing the product, only aligning it with how American healthcare is regulated and delivered. For companies like Emerald, the opportunity to expand into the US is real, exciting, and achievable with the right strategy in place.
If you are exploring a US expansion for a preventive or remote patient monitoring platform, early regulatory strategy can significantly reduce risk and time to market. Contact us to discuss FDA pathway planning, predicate strategy, and how to bring your product to the US efficiently.