BodyTel Successfully Completes ISO13485 Audit
BodyTel Scientific Inc. (OTCBB: BDYT), a developer of wireless telemedical devices, announces today that it has, through its wholly owned subsidiary and legal manufacturer of the GlucoTel, BodyTel Europe GmbH, successfully completed its initial ISO 13485:2003 Certification Audit through its notified body NSAI – National Standards Authority of Ireland.
ISO 13485:2003 Certification is recognized as a worldwide quality certification specific to the Medical Device industry. The ISO certification as well as a successfully reviewed Technical File is required for a company to sell any medical device in the European Union and Canada. In order for the company to receive a European Community certificate for its GlucoTel product, the company had to demonstrate during the audit that the design and performance of the GlucoTel meet the requirements of the quality standards and directives.
BodyTel’s successful audit confirmed that the company’s quality system was found to meet the requirements established by the EU and other international authorities. Based on audit results, BodyTel was recommended for certification. Certification is expected before the end of the first quarter.
Stefan Schraps, CEO & President of BodyTel, said, “The ISO Audit was a resounding success and we are delighted and proud of what we have achieved. Having a successful ISO audit, along with the pending review of our Technical File, means that we are getting closer to European product launch of the GlucoTel. These are very exciting times for all of us.”
BodyTel’s next steps are to complete international clinical studies with the GlucoTel, apply for a Canadian license and move forward to obtain U.S. FDA clearance.
BodyTel’s first market-ready product identified in the scope of the ISO audit and Technical File is the GlucoTel™ blood glucose monitoring and diabetes management system. It supports patients and doctors in the treatment of diabetes and its corollary diseases. GlucoTel™ electronically measures the blood sugar level and then sends test results using Bluetooth technology to the patient’s cell phone. Data is then automatically transmitted to an online database via internet connection and stored long-term. To facilitate better diabetes management, the patient and any authorized persons, e.g. healthcare professionals or caregivers, can access the data via internet for review.
About BodyTel
BodyTel is a German-American telehealth company that specializes in telemedical monitoring and management systems for chronic diseases. The company combines its know-how in telecommunications, internet and medical technology/diagnostics to create new products and services for the changing needs of global health. BodyTel products are designed not only to simplify home monitoring by patients, but also to ease the communication of ‘measured body values’ to healthcare professionals or other caregivers by bridging the gap between the patient and the caregivers instantaneously and in real-time. BodyTel’s products – GlucoTel, PressureTel and WeightTel are each at different stages of development and approval processes. BodyTel holds a 50% interest in GlucoTel Scientific Inc. which holds the rights to the GlucoTel™ blood glucose meter technology.
Further information can be found at www.bodytel.com.
Forward Looking Statements
Statements in this news release that are not historical are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,”"plans,”"anticipates,”"believes,”"intends,”"estimates,”"projects,”"aims,”"potential,”"goal,”"objective,”"prospective,” and similar expressions, or that events or conditions “will,”"would,”"may,”"can,”"could” or “should” occur. Forward-looking statements in this news release include: Based on audit results, BodyTel was recommended for certification. Certification is expected before the end of the first quarter, that the ISO Audit was a resounding success, Having a successful ISO audit along with the pending review of our Technical File means that we are getting closer to European product launch of the GlucoTel and that BodyTel’s next steps are to complete international clinical studies with the GlucoTel, apply for a Canadian license and move forward to obtain U.S. FDA clearance. It is important to note that the Company’s actual outcomes may differ materially from those statements contained in this press release. Factors which may delay or prevent these forward looking statements from being realized include, but are not limited to those concerning the timing of regulatory approval or commercialization of its products or the achievement of any other clinical, regulatory or product development milestones or other risk factors and matters set forth in the Company’s Annual Report on Form 10-KSB for the year ended February 28, 2007 and the Company’s periodic reports filed with the SEC. These reports are available on our investor relations website at www.bodytel.com and on the SEC’s website at http://www.sec.gov. BodyTel undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.