From rxpgnews.com
FDA Gives Clearance to a Portable Reagentless CO-oximeter
By NIR Diagnostics Inc.,
May 13, 2005 - 10:26:38 AM
NIR Diagnostics Inc. (TSX Venture:NID), an innovative developer of handheld reagentless medical instruments
based on its proprietary near-infrared light technology, announced today that its 510(k) submission for HemoNIR(TM)LAB (for laboratory use) has been awarded clearance by the United States Food and Drug Administration (FDA).
FDA clearance allows NIR Diagnostics to market the HemoNIR(TM)LAB 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 (HPB) approval.
"FDA clearance of HemoNIR(TM)LAB demonstrates the commercial capability of our near-infrared platform to monitor blood analytes," said Duncan J.MacIntyre President, CEO and Executive Vice Chairman of NIR Diagnostics."Near-infrared light offers the potential of a new standard for in-vitro and in-vivo blood testing compared to blood tests that use costly and environmentally damaging chemical reagents."
HemoNIR(TM)LAB is the first medical product from NIR Diagnostics' spectroscopic technology platform to obtain FDA approval. HemoNIR(TM)LAB, which will sell for less than $5,000, offers laboratories an alternative to expensive tabletop CO-oximetry equipment that sells for as much as $45,000 and requires a painful arterial syringe blood sample drawn by a physician.
Since NIR Diagnostics submitted the HemoNIR(TM)LAB 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 United States and file a point- of-care 510(k) submission with the FDA for HemoNIR(TM). This clearance will allow for additional use of the device on board emergency vehicles, and in military, mining and chemical plant applications.
No handheld device exists that is capable of measuring the combination of total hemoglobin (internal bleeding) and carboxyhemoglobin (carbon monoxide poisoning) for on-site
emergency use. NIR Diagnostics' technology is designed to make blood testing convenient and accessible to a broad population of potential users, just as handheld wireless devices have increased the adoption and expansion of
electronic messaging.
About HemoNIR(TM)
The HemoNIR(TM) device is the only handheld reagentless device that measures the ability of a person's blood to carry oxygen by monitoring total and non-functional hemoglobin from a drop of blood. HemoNIR(TM) specifically
measures carboxyhemoglobin, methemoglobin, and total hemoglobin in whole blood without the use of expensive and environmentally dangerous chemical reagents.
On the basis of receiving FDA clearance the Company is now in discussions with potential partners to license HemoNIR(TM) and intends to seek corporate alliances with global device companies that are capable of working with NIR
Diagnostics to bring new technology such as CardioNIR(TM) (cholesterol) and GlucoNIR(TM) (glucose) to market.
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