Intelesens, a Belfast-based healthcare technology spin-out company from the University of Ulster, is set to enter the massive American healthcare market after getting the green light from US authorities for a pioneering health monitoring device. 

Intelesens is a leading innovator in non-invasive vital signs monitoring equipment, much of it highly miniaturised, lightweight, unobtrusive and easily worn under clothing, used in remote patient monitoring and personal telehealth.

Following successful clinical trials in Massachusetts General Hospital in Boston, the US Food and Drugs Administration (FDA) has awarded Class 2 regulatory approval to Intelesens’ new “Aingeal” device for use in US hospitals and healthcare organisations.  

The wearable product enables patients to be monitored, continuously and wirelessly, from the moment they arrive in hospital until discharged. 

The FDA decision is the second significant United States commercial boost this year for Intelesens, which is a leading light in the burgeoning technology-driven connected health sector. 

In April, it showcased its technology in Silicon Valley, the heartland of US high-tech innovation, and scooped a top prize in the 2011 ITLG /Irish Times Irish Technology Leaders Group Awards. It was named the “Most Promising Technology Company” at the awards   ceremony, held at Stanford University in San Jose, California. 

Intelesens was founded by three biomedical professors at Ulster, John Anderson, Jim McLaughlin and Eric McAdams, and the University retains a significant shareholding in the company. Key technologies which the trio spun out from the University comprise the solid, science-based foundation for the company’s industry-leading products. 

To date, the company has been funded from local sources, including leading venture capital provider, Enterprise Equity. Invest Northern Ireland is a shareholder and has provided Research & Development grant support. The Wellcome Trust and Intertrade Ireland have provided further financial support for ongoing R&D and the Trust remains a shareholder in the company. 

Michael Caulfield, Intelesens CEO, said:  'We have always aspired to take our unique monitoring technology to the global healthcare market and this formal validation by the US FDA regulatory authorities means that we can now move forward rapidly with the launch of our Aingeal product into the US Hospital sector, likely to begin in early 2012."  

The company already has a strong foothold in the home monitoring market with its V-Patch product, which obtained European CE approval in 2009. 

Professor Jim McLaughlin, Director of the Nanotechnology and Integrated Bioengineering Centre (NIBEC) at the Ulster’s Jordanstown campus, said: “NIBEC and Intelesens have a dynamic collaborative relationship and it is clear that this is a company that is going from strength to strength. 

“FDA approval is a huge boost for Intelesens and for Northern Ireland’s profile as a leader in international connected health. Intelesens’ success is a graphic demonstration of how University of Ulster spin-outs are producing an impact on both the economy and the well-being of our citizens.” Where patients are restricted to their hospital beds, the “Aingeal” body-worn monitor allows free movement, promoting physical activity and recovery.

“Aingeal” is unique in that it measures the patient's ECG, heart rate, temperature and motion and sends that information wirelessly so that it is immediately and easily accessible by nursing and other medical staff. For the first time however, this device also measures the patient's respiration rate.

Clinicians can access the patient data through any web browser, freeing them from paper charts and records and reducing the costs of taking routine observations.