11.11.2015
ForaCare Suisse AG Issues Updated Declarations of Equivalence
ST. GALLEN, Switzerland, November 11, 2015 / ForaCare Suisse AG located in St. Gallen, Switzerland, announced today it is issuing updated Declarations of Equivalence (DOE) for its FORA® Diamond and Comfort lines of blood glucose monitors.

ForaCare strives to provide users with the most advanced technologies while maintaining the highest standards in the industry.  As part of ForaCare’s efforts to continually improve its products, the company conducts internal and external clinical validations that go above and beyond regulatory and CE requirements. 

Widely recognized for their innovation and accuracy, ForaCare’s monitoring devices have been used in clinical trials including randomized trials.  Most recently, FORA G31b, a blue tooth enabled blood glucose-monitoring device was used in a study evaluating Telehealth in the treatment and management of diabetes.  The study entitled “A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes” was published in a June 2015 issue of the Diabetes Technology & Therapeutics journal.
http://www.ncbi.nlm.nih.gov/pubmed/26154338

“We conduct clinical validations using a blood glucose monitoring system that is identical to another system,” said Ty-Minh Tan, CEO of ForaCare Suisse AG. “We are happy to report that our FORA® Diamond and Comfort products exceed the minimum ISO and ANSM requirements.”

ForaCare declares that devices validated by the following institutes use the same test strip formulas in its COMFORT line: / 4308 / GOD / 0.5uL / 5 seconds and the IC chip on the BGM system and are therefore identical in nature and manufacturing to FORA® COMFORT Plus G30, FORA® COMFORT Voice V30, FORA® COMFORT Advance G31 and FORA® COMFORT Mini G71 for the BGM capability.

FORA® Diamond devices validated by the following institutes use the same test strip formulas  / 4365 / GDH-FAD / 0.5uL / 5 seconds and the IC chip on the BGM system and are therefore identical in nature and manufacturing to FORA® Diamond PRIMA (DM10), FORA® Diamond VOICE (DM20), FORA® Diamond MINI (DM30) and the FORA® Diamond GD50 (GD50) for the BGM capability.

All ForaCare monitoring devices are validated as highly accurate in the industry and provide superior quality directly to consumers.  FORA® Blood Glucose Monitors are validated according to ISO 15197 requirements at an internationally renowned diabetes institute in Ulm, Germany.

ForaCare devices comply with new ISO standards and have completed third party validations:

  • FORA® Diamond strips (for the Diamond series) is clinically validated in the Czech Republic and Switzerland and are proven to meet the +/- 15% required by the new ISO 15197:2013. 
  • FORA® Comfort Pro GD40 (with 5-electrode technology) is clinically validated in Switzerland and is proven to meet the +/- 15% required by the new ISO 15197:2013
ForaCare provides FDA cleared and CE marked innovative health monitoring devices that provide simple connection to the FORA system. For more information, please visit http://www.foracare.ch/

About ForaCare Suisse AG: http://www.foracare.ch/

Contact:

Elena Birrer
+41-71-220-1001
Email: elena.birrer@foracare.com
Website: http://www.foracare.ch

SOURCE ForaCare Suisse AG

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