KarmelSonix Pulmonary Device Approved
Australian based KarmelSonix, Limited received approval from the FDA for their new device, WIM-PC. News of the approval was shared with a press release from the company.
The WIM-PC entails two phonopneumography sensors that are attached to the patient’s chest and neck near the windpipe. Also included is a chest expansion belt, which evaluates breathing activity. An ambient noise microphone is also integrated with the device, which prevents interference from environmental noise.
These components are attached to a computerized system, which digitizes signals from the sensors. This pulmonary function testing device is based on wheeze quantification. Analysis is performed by calibrated algorithms that detect cough, wheeze, and respiration.
The tool is useful for the diagnosis of asthma and can also be used while patients are sleeping, particularly useful for diagnosis of nocturnal asthma. This device provides an alternative assessment technique to standard spirometry testing, which can be difficult for some patients to complete such as young children and the elderly.
The tool is intended to analyze, interpret, and document sounds from the lungs. It is to be used under the supervision of a physician and can be utilized during provocation testing that calls for acoustic pulmonary function measurement with wheezing quantification.
The company is now working on approval for the device with the European CE Mark and the Australian approval process.
November 14, 2007 Related topics: Pulmonary, Product Approval & Certification, New Technology & Innovation, Monitoring