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WirelessDevNet.com Press Release
BodyTel Scientific Seeks FDA Approval for Its Wireless Blood Glucose Monitoring Device 'GlucoTel'
HENDERSON, Nev., -- BodyTel Scientific Inc. (OTCBB:BDYT), a company focused on the development of innovative wireless healthcare products, announces that the company has begun the U.S. Food & Drug Administration (FDA) clearance process for its blood glucose monitoring device, GlucoTel. The company has chosen MDC Associates, LLC (www.mdcassoc.com), FDA consultants, to assist BodyTel with the applications and tests required in the approval process.
Currently, the GlucoTel system is in the pre-IDE (investigation of device evaluation) phase of the FDA review process. The FDA has reviewed and confirmed that BodyTel's clinical study design is acceptable. Clinical studies are being planned and are scheduled to begin within the next 30-60 days. BodyTel anticipates submitting the necessary 510(k) application to the FDA in fall, receiving clearance to market the GlucoTel system in the U.S. before the end of the year.
"Now that we have completed the manufacturing of the first conforming samples of the GlucoTel meter, we are excited to begin the clinical trials. We are confident we will successfully reach the end points of the trial and demonstrate the user-friendliness of our meter. With the FDA clearance, we will be ready to market GlucoTel in the United States and all countries requesting this certificate," stated Stefan Schraps, CEO of BodyTel Scientific.
The GlucoTel monitoring device is a part of the GlucoTel self-managed telemedical diabetes system. It supports patients and doctors with the treatment of diabetes and its resulting illnesses. The blood sugar measuring instrument determines the sugar level electronically and transmits it automatically via Bluetooth to the patient's mobile phone. The data is then sent per text message (SMS) or data package (GPRS) directly to an internet database and stored long-term. The system enables the inclusion of the patient in their own treatment and improves the information basis and communication between doctor and patient.
About BodyTel Scientific
BodyTel Scientific Inc. is a company focused on the development of innovative wireless health monitoring products. Please visit www.bodytel.com for more company information.
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