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KarmelSonix Receives European CE Mark For WHolter Device

KarmelSonix (KSX) has received European CE mark for wheeze and cough ambulatory recorder WHolter.

WHolter is used to record the respiratory sounds and breathing activity of patients who suffer from Asthma, COPD and chronic cough.

The grant of the CE Mark is a mandatory requirement prior to enabling sales and distribution of the device in Europe to commence. It is also the basis for obtaining regulatory approvals in non-European jurisdictions such as the TGA in Australia. To receive the CE Mark, the product has to withstand stringent independent tests of safety and performance.

KarmelSonix said that WHolter allows data to be recorded overnight while the patient sleeps, or during the day at school, work and during sports. As such, it provides critical information on the wheeze and cough activities while patients are away from the doctor’s clinic and in their own allergen, dust, pollen and irritants environment.

Typically, the unit is applied to the patient at the clinic, which then receives the unit back from the patient with the recorded data from either 8 or 24 hours of continuous recording. The data is then uploaded to a Panalysed by KarmelSonix’ PulmoTrack WHolter analysis software.

Noam Gavriely, professor, CEO and CMO of KarmelSonix, said: “The WHolter is a key component in our product development program. The ability to obtain objective and quantitative information on nocturnal asthma and cough and on occupational obstructive respiratory symptoms is a step change in physicians’ ability to manage asthma and cough.

“In addition to marketing the WHolter as a free-standing device, KarmelSonix’ revenue stream will benefit from sales of disposable elements (sensors, adhesive pads) and from providing analysis and interpretation services using its WHolter-Lab experts at its KarmelSonix (Israel) Haifa facility, making this program more than one of only selling our WHolter equipment.”