UK manufacturer first to achieve UKCA mark for wearable sensors and remote patient monitoring platforms

Isansys Lifecare, a global leader in digital healthcare and AI applications, today announced it has received UKCA Full Quality Assurance Certification for its clinical wearable sensors and continuous patient monitoring platform, the Patient Status Engine (PSE). This important milestone 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 UK early next year.

The ground-breaking 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 innovative and first of its kind 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.

Julian Jones, chief compliance and regulatory affairs officer at Isansys, said: "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 of stress whilst making patients feel safe. The UKCA certification for the Isansys Patient Status Engine 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 news of 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).