HEALTH CANADA GRANTS HEMONIR-LAB DEVICE LICENSE
Health Canada has granted a new medical device license to NIR Diagnostics, a developer of handheld reagentless spectroscopy based medical instruments, for its HemoNIR-LAB, allowing the company to sell the device for blood testing in laboratory use only in Canada.
HemoNIR-LAB uses NIR Diagnostics' near-infrared light technology to diagnose life-threatening problems such as internal bleeding or carbon monoxide poisoning. Health Canada licensed HemoNIR-LAB based on the company establishing safety and effectiveness of the device.
The company also announced that it is initiating clinical trials at three separate sites in the U.S., which will assist the company in filing a point-of-care 510(k) submission for HemoNIR with the FDA during the third quarter and a Health Canada application later in the year. This clearance will allow for broader use of the device, outside of the laboratory, on board emergency vehicles and in military, mining and chemical plant applications.