PD Monitor CE MarkClearSky’s PD-Monitor, a device designed to assist with the diagnosis of Parkinson’s, has achieved CE Mark approval.

A CE mark indicates that the medical device has met all applicable directives of the European Commission and, subsequently, the laws and regulations of the European Union member states. The PD-Monitor can therefore be marketed within the 30-nation EEA and Switzerland.

The establishment of this CE mark conformity involved thorough evaluation and testing of the PD-Monitor.

Diagnosis of Parkinson’s can be difficult to confirm by conventional clinical assessment alone. The PD-Monitor assists the specialist by measuring symptoms of Parkinson’s while patients undertake routine clinical tasks.

Small, non-invasive sensors are positioned on the finger and thumb measure patients’ movements in response to the finger-tapping test, a clinical task in which the patient repeatedly taps the forefinger and thumb of each hand for a period of 10-30 seconds.

Readings from the sensors are transmitted to a tablet computer and then analysed by specialist software employing biologically inspired algorithms. These algorithms have been trained to recognise patient movements characteristic of tremor and bradykinesia, two important symptoms of Parkinson’s.

The CE mark is also an important pre-cursor to regulatory approvals in other parts of the world, such as China. ClearSky is actively seeking distributors and licensing partners to bring the technology to the much needed patients and their care providers.

Please contact us if you are interested in becoming a distributor or licensing our technology.