Aingeal Gets FDA Clearance
Intelesens, the Belfast wireless health monitoring company, who last month won the prestigious Most Promising Technology Award at the 4th Annual Silicon Valley Technology Leaders Awards in San Jose, California, today received formal confirmation that their wearable wireless hospital monitor, Aingeal, has been awarded class 2 regulatory approval by the FDA authorities in the USA. Following the completion of successful clinical trials in Massachusetts General Hospital in Boston last year, FDA clearance now enables the company to deploy Aingeal into US hospitals and healthcare organisations. Aingeal received its European CE class 2 approval last year.
The Aingeal device enables patients to be monitored, continuously and wirelessly, from the moment they arrive in a hospital until the time they are discharged. Where currently monitored patients are restricted to their hospital beds, the Aingeal body worn monitor allows free movement, promoting physical activity and recovery. The Aingeal device 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.
Intelesens CEO Michael Caulfield commented - 'This has been a tremendous result following many months of meticulous testing and data gathering by the engineering and quality teams in Intelesens, who had to work very closely with the US regulatory authorities. Aingeal has been designed so that it can be used to monitor those patients who are moving around the hospital as well as those who are confined to beds. Typically only 40% of hospital beds are monitored - this technology, for the first time, opens up the opportunity to provide low cost, ubiquitous vital signs monitoring for all patients within a hospital.'
The company is now working with distribution partners and predicts that Aingeal will be deployed in a number of US Hospitals by early 2012.