What is the Koala Sleeve?
The Koala Sleeve is a wearable sleeve under development, designed for continuous blood pressure monitoring.
How is it different from a conventional blood pressure monitor?
Conventional cuff-based monitors take individual readings. The Koala Sleeve aims to monitor blood pressure continuously, providing a more detailed record of changes over time.
What will the system include?
The planned system includes a sleeve, a compact controller and an app. The controller is intended to transmit data via Bluetooth to a compatible smartphone or smartwatch.
Will it provide alerts?
A vibration alert for high blood pressure is a planned feature. Its functionality and performance will need to be evaluated during development.
Who is it being developed for?
Potential applications include personal monitoring, remote patient monitoring and clinical settings. Suitability for each application will depend on validation and applicable regulatory requirements.
Is the Koala Sleeve available to buy?
It is currently presented as a development project. A commercial launch date has not been announced.
Has it been clinically validated?
Clinical studies are planned. The project materials do not establish that clinical validation has been completed.
Can it replace my existing blood pressure monitor?
It has not yet been established as a replacement for a validated blood pressure monitor. That will depend on clinical evidence and the relevant regulatory authorization.
Will it require regulatory approval?
Requirements will depend on the intended use, product claims and country of sale. Regulatory status will be confirmed before it is marketed for medical use.
How much will it cost?
Final pricing has not been announced.
Will health insurance cover it?
Coverage has not been established. Reimbursement will depend on the market, insurer, clinical evidence and any required regulatory authorization.