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Full approval for Patient Status Engine

End-to-end platform is a Class IIa medical device providing real-time physiological data.

20th June 2022

Innovation in Textiles
 |  United Kingdom


Isansys Lifecare has received UKCA full quality assurance certification for its clinical wearable sensors and continuous patient monitoring platform, the Patient Status Engine (PSE).

This is a first for a UK company and will ensure that patients, hospitals and other healthcare providers across the UK continue to benefit from the Isansys technology following the cut-off date for updated medical device compliance requirements in the country early next year.

The technology simply and automatically collects and analyses patients’ vital signs, helping to inform clinical decision-making and enabling timely interventions that enhance the care and safety of patients in hospital or at home. The PSE is an end-to-end platform that is also a Class IIa medical device providing real-time physiological data, early warning scores, predictive analytics and digital bio-markers across a broad range of medical conditions and patient pathways.

“At Isansys we aim to provide clinicians and nurses with unique care enhancing technology so they can eliminate unexpected critical events in the hospital, reduce hospital admissions, shorten hospital stays and relieve frontline staff whilst making patients feel safe,” said Julian Jones, chief compliance and regulatory affairs officer at Isansys. “The UKCA certification for the PSE is a vital step towards increasing and maintaining the adoption of our new technology within hospitals and healthcare organisations in the UK.”

Headquartered in Oxfordshire, Isansys has a subsidiary in Germany, a related company in India and is working with partners globally.

The UKCA mark announcement follows the company’s success in becoming one of the first wireless patient monitoring manufacturers to achieve EU MDR certification of its quality management system (QMS) under the new Medical Device Regulation (MDR) (EU 2017/745 ) now in force in the European Union (EU).

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