FDA Clears NIR Diagnostics' HemoNIR

NIR Diagnostics, a developer of handheld reagentless medical instruments based on its near-infrared light technology, announced that its 510(k) submission for HemoNIRLAB (for laboratory use) has been awarded clearance by the FDA.

FDA clearance allows NIR Diagnostics to market the HemoNIRLAB device, and coincides with the company's European CE mark compliance and the company's most recent ISO 13485 global accreditation -- a prerequisite for Canadian Health Protection Branch approval.

Since NIR Diagnostics submitted the HemoNIRLAB regulatory application, healthcare and medical personnel have requested that the company also secure FDA clearance for point-of-care use. NIR Diagnostics will immediately initiate trials in Canada and the U.S. and file a point-of-care 510(k) submission with the FDA for HemoNIR. This clearance will allow for additional use of the device on board emergency vehicles, and in military, mining and chemical plant applications.