FDA approves KarmelSonix's home asthma assessment device

KarmelSonix, a developer and marketer of asthmatic and pulmonary devices, has received Food and Drug Administration approval for its device, the WIM-PC.

KarmelSonix specializes in the analysis of sounds emitted from the body (specifically, wheezing) heard in asthmatic patients. The device consists of a sensor attached to the patient’s neck and chest near the windpipe, and a computerized system that analyzes the sounds and determines whether the sounds indicate a life threatening situation requiring the sufferer to be admitted to hospital, or whether the condition can treated at home or at a clinic.

The Australian-traded company is a merger of Karmel Medical and PulmaSonix. Founded in 1996 under the name Karmel Medical, the company has raised $8 million and it even received FDA approval for its device (a previous generation of the WIM-PC), but the company’s inability to market the product proved more difficult than anticipated. Karmel Medical eventually merged the company with an Australian shell called PulmaSonix, and a third company.

KarmelSonix recently raised $6 million (US$5.3 million) on the Australian Stock Exchange at around 17 cents per share in U.S. dollars.