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.