Israeli company KarmelSonix reported today that it has received approval of the CE device – Wholter. This certification allows the company to sell the product in Europe. Based on this approval the company could receive additional regulatory approvals such as the TGA in Australia. In order to receive this, the device mustmeet strict tests of independent safety and performance.
KarmelSonix company focuses on manufacturing, marketing, and selling products that are non invasive in the acoustics of the lungs to manage lung disease. The company received the OK for the device to record the sound of breathing in patients with asthma.
KarmelSonix is run by Professor Noam Gavrieli and is a public company whose shares are traded on the Australian Stock Exchange.
KarmelSonix technology offers immense advantages with respect to the capture, storage and analysis of respiratory sounds objectively and without relying on patient cooperation.
KarmelSonix is dedicated to providing a full range of products, all based on its core technology, but implemented in the configuration that is most appropriate for its use – from a patient’s home to the Intensive Care Unit.
KarmelSonix Ltd is a joining of two sector leaders, each with a unique proprietary respiratory acoustic technology:
- KarmelSonix (Israel): Passive technology; an ingenious technique to listen and analyze the lung acoustics generated during the respiratory cycle.
- Pulmosonix (Australia): Active technology that focuses on injecting sounds into the thorax and picking the changed signal at various locations, reaching diagnostic conclusions from the sound propagation data.
The synergy between the technologies and the ability to combine the two approaches, allows Karmelsonix to offer solutions no other market player can tackle. It resolves clinical challenges previously deemed impossible.