What FDA clearance and our Work with Mount Sinai Means for Proactive Healthcare

Today, we’re announcing that we’ve received Class II clearance from the U.S. Food and Drug Administration (FDA) for hospital care. With our FDA clearance, we’re now one step closer to our goal of keeping every person across the globe healthy, safe and alive.

This company was built from nothing more than an idea. It is not an academic spin-off. We bootstrapped to a prototype and our first clinical study, then achieved CE marking and now have FDA clearance. We have our remarkable, hardworking team to thank for where we are today, and perhaps more importantly, where we’re going. This talented group of Ph.Ds, data scientists, engineerings, salespeople and customer success leaders work each and every day to move our industry further, improve patient outcomes and lessen the burden on healthcare professionals.

We’ve had regulatory clearance in the U.K. since March 2017 and we’re now thrilled to bring our remote patient monitoring solution to leading U.S. healthcare organizations, including Mount Sinai Health System in New York.

Our goal is to work closely with our provider partners like Mount Sinai to deliver proactive healthcare and create healthier communities. Over the next 18 months, we’ll be focusing on building out our platform to predict health trajectory – helping to deliver healthcare even earlier.

Our secure, HIPAA-compliant platform is powered by our all-in-one wireless wearable, which passively and continuously monitors vital signs with ICU-level accuracy. Our platform delivers proactive healthcare earlier, helps patients feel safer and more secure, and, in the U.K., we’ve demonstrated reduced hospital readmissions and reduced pressure on staff. We use proprietary algorithms to continuously analyze data, along with relevant contextual patient information, to offer actionable and proactive insights into the wearer’s health.

Why it matters

By 2030, the population of people age 60 or older will grow by 54 percent to 1.4 billion and will almost double to 2.1 billion people by 2050. This demographic transformation requires a paradigm shift from reactive to proactive healthcare. Unless society trains and hire tens of thousands more doctors and nurses to manage these demographic changes, we must multiply the efforts of our existing healthcare professionals.

Across the U.S. and the U.K., we’re working with top-tier hospital providers and home healthcare agencies to help them create a new delivery model, one that provides proactive healthcare sooner — and before we even know we need it — streamlines clinical workflows, and reduces fatigue and stress on physicians and nurses.

Unnecessary Emergency Department (ED) visits and hospital readmissions costs U.S. hospitals more than $40 billion annually. Readmissions and ED visits also take a devastating physical and emotional toll on the individual going into the hospital. We solve this by combining continuous wireless monitoring and advanced data science, which allows clinicians to monitor patients in real-time and gain immediate insights into the patient’s health.

Having patient-specific insights in real time lets healthcare professionals spot deterioration faster for earlier intervention. It also helps alleviate the stress doctors and nurses face by eliminating burdensome, manual processes, such as data and vital sign collection, allowing them instead to spend more time caring for their patients and less time collecting data.

What’s next? Predictive digital therapies

A human cannot look at hundreds of thousands of data points and detect a pattern in less than one second —  a computer can. Using artificial intelligence (AI) to recognize illness sooner and enable earlier treatment will save lives and prepare the world’s healthcare systems for the future.

However, AI has become a buzzword. Many promise that they are doing AI but yet do not have the data or a strategy to capture the data required to train machine learning models. We specifically built our wearable in order to capture real-time, trusted and valid data on physiology.

This approach lets us realize a world where everyone’s health is centrally monitored and where unexpected health deterioration is a thing of the past.

The first step in achieving this mission is to build deep insight into individual human health, so we’re partnering intensively with our customers to do this. Our device captures a range of real-time physiological data streams, which is then seamlessly integrated with other third-party devices to capture even more metrics. As a result we can now track more vital signs than anyone else today.

We are using all of this data to build digital therapeutics, which predict disease and recommend therapies directly to the patient. On an individual level, this will save lives, and on a societal level, this will reduce the strain on our healthcare resources.

If we can support your organization reduce unnecessary ED attendances and hospital readmissions, please get in touch here.