Medical grade smart T-shirt receives CE mark

Chronolife, an artificial intelligence company specialising in digital health, has secured Class IIa medical certification from the European Union for its medical grade smart T-shirt, KeeSense.

The multi-sensor wearable device continuously monitors electrocardiography (ECG), thoracic respiration, abdominal respiration, skin temperature, thoracic impedance, and physical activity, enabling healthcare practitioners to remotely track vital clinical data about their patients. The platform’s receipt of a CE mark allows KeeSense to be marketed in the European Economic Area as a wearable medical device for healthcare purposes including remote monitoring of patients with chronic diseases and support for diagnostics. 

The KeeSense T-shirt is designed for round-the-clock use, and is fully reusable and washable, mimicking similar daily use garments. The T-shirt transmits data to its paired smartphone app via Bluetooth, which then sends the data to a server for live or time-delayed analysis by the wearer’s healthcare team. The platform’s multi-parametric medical data enables researchers and healthcare teams to develop meaningful insights into patients’ long-term health, while also allowing prompt responses to medical emergencies.

Besides providing healthcare practitioners with a powerful new way to follow their patients, Chronolife’s Remote Patient Monitoring (RPM) platform will also enable pharmaceutical and medtech researchers to leverage a new source of physiological data to run more therapeutic efficiency programs and clinical trials. KeeSense monitoring is intended to be unobtrusive and to blend seamlessly with daily life. Healthcare stakeholders would be able to remotely and continuously monitor patients under real-life conditions. 

Laurent Vandebrouck, CEO of Chronolife, said: "KeeSense delivers an unrivalled stream of real-world medical-grade data. This medical CE mark enables doctors to use KeeSense to provide more convenient and effective medical care, and gives researchers access to a rich new source of vital signs intelligence.”

Chronolife also recently launched a major, pan-European clinical trial of a predictive solution using KeeSense to provide early warning of cardiac emergencies in patients with chronic heart failure. Researchers at 25 hospitals across Europe will collect KeeSense data to develop and validate the ability of Chronolife’s predictive HOTS algorithm to accurately alert healthcare providers of clinically significant events that signal deterioration in their patients’ conditions.