BodyTel Scientific Inc. (OTCBB:BDYT), Henderson, Nev., 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
(http://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.
For more information, visit www.bodytel.com or call 212/505-5976.
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