May 1, 2003 - Bortec Biomedical issues declaration ...      printable (PDF) format

Declaration of Conformity      printable (PDF) format

January 21, 2003 - Bortec Biomedical receives ...      printable (PDF) format

May 1, 2003 - Bortec Biomedical issues declaration of conformity for CE marking of the AMT-8

Calgary, AB, May 1, 2003 --- Bortec Biomedical Ltd. a research and scientific device solutions provider based in Calgary, AB, has recently issued a Declaration of Conformity ensuring that the AMT-8 complies with the necessary requirements for CE marking. This allows for expanded marketing potential into the European Union for Bortec’s AMT-8 electromyography signal acquisition system.

Dr. Scott Day, President and CEO at Bortec Biomedical commented that “We consider CE marking of our product an important milestone. It shows that Bortec can manage the regulatory requirements of the Medical Devices Directive ensuring all technical aspects of our products conform to these regulations. Additionally, Bortec believes that the CE marking of our product will allow us to access markets previously unexplored and ultimately increase our presence in the research community at large.”

The AMT-8 is currently in use around the world in leading research laboratories utilizing electromyography as a key component of their research. With the ability to place the CE mark on the AMT-8, Bortec will be able to expand its market presence into the European Union ultimately increasing the sales and use of its products into this very important geographical market. Bortec currently has an exclusive distribution agreement with Tracksys Ltd., based in the United Kingdom for distribution into Ireland and the UK.

For more information about Bortec Biomedical Ltd., please visit the website at www.bortec.ca or phone 403.237.8144.

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January 21, 2003 - Bortec Biomedical receives 510(k) substantial equivalence letter from US FDA for AMT-8 and accessories

Calgary, AB, January 21, 2003 --- Bortec Biomedical Ltd. a research and scientific device solutions provider based in Calgary, AB, has recently received a substantial equivalence determination from the US Food and Drug Administration for its flagship product, the AMT-8 allowing for expanded marketing potential and field of use.

Dr. Scott Day, President and CEO of Bortec Biomedical commented that “With Bortec achieving this milestone of substantial equivalence for our AMT-8 product, we are advancing the use of EMG into larger, clinically relevant settings. This will result in a bridge being created between cutting edge EMG research and its application in the clinical environment, leading to better patient care.”

The AMT-8 is currently in use around the world in leading research laboratories utilizing electromyography (EMG) as a key component of their research. With the issuance of the FDA 510(k) substantial equivalence letter, Bortec will be able to expand its market presence into a number of clinically important settings involving a greater range of health care professionals.

For more information about Bortec Biomedical Ltd., please visit the website at www.bortec.ca or contact Dr. Brett Schönekess at 403.237.8144.

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