University of Ulster healthcare technology spin-out company, Intelesens, is set to expand into new global markets after receiving CE regulatory approval for its life-saving wireless health monitor product, Vitalsens.
CE marking is a mandatory European approval for medical devices to indicate conformity with the essential requirements set out in European Directives. This milestone opens up extensive new markets in Europe and South-East Asia to the Belfast firm, whose products build on sensor technologies developed by the company's founders at the University of Ulster.
The Vitalsens device is made up of a disposable electrode patch and a reusable clip-on transmitter, and offers a low-cost technology solution to help in the management of care for both chronically ill patients at home, as well as monitoring the health of both in-patients and out-patients attending hospital.
Intelesens Chief Executive Michael Caulfield said: “Data relating to the wearer's health, including heart rate, ecg, temperature and levels of activity are measured in the chest area and transmitted via Bluetooth to software residing on a pc or laptop in the wearer's home or in a hospital ward. This vital health information can then be accessed by medical professionals either locally or remotely, and appropriate treatments delivered rapidly.”
The CE accreditation is an important step in the growth of the company, said Caulfield. But there is more to come.
“The next step is to gain US FDA ( Food and Drug Administration) approval for the product. That will open up the enormous US market to us, taking our business – built on technology developed in Northern Ireland – to a whole new level.”
Intelesens recently showcased its products at the international Medica Medical Device conference and exhibition in Dusseldorf, Germany.