Established in 2007, Ultramedix Australasia Pty Ltd is an Australian owned company staffed by medical imaging experts, engineers and medical clinical professionals. We are a leading supplier of diagnostic ultrasound imaging equipment. This website is specifically for Ultramedix's non invasive technology devices for home use by diabetics and further information about our other products is available at www.ultramedix.com.au
The GlucoTrack is distributed in New Zealand by GlucoTrack NZ Limited in co-operation with Ultramedix.
We have long shared an intense fascination with new and innovative technology, particularly that of non-invasive technology to overcome the barriers many diabetes sufferers have towards monitoring themselves more frequently. Non-invasive glucose monitoring has long been the dream of many researchers and companies but has unfortunately been characterized by hype and premature announcements and has been fraught with technological barriers for decades.
Finally though the GlucoTrack device has overcome these barriers and is the product of years of intensive research by Integrity Applications in which they determined the technical challenges required to increase signal to noise ratio by simultaneously combining three independent technologies. The GlucoTrack utilizes a patented combination of ultrasonic, electromagnetic, and thermal technologies which measures these three distinct criteria with a unique algorithm to weigh each measurement and calculates the weighted average to provide an accurate glucose measurement.
This innovative approach was recognized by Frost & Sullivan who granted Integrity Applications a Product Innovation Leadership award.
GlucoTrack enables diabetics to measure their blood glucose levels without drawing blood and removes the two most significant barriers to frequent monitoring: pain (the device is non-invasive) and cost (no disposables are required). A small sensor clips comfortably to the ear lobe while blood glucose level is calculated using a proprietary algorithm and displayed on a hand held device the size of a smart phone.
The benefit of a device that eliminates pricking of a finger and drawing blood each time a blood glucose level is required is enormous. Nurses, caregivers and elderly patients will immediately recognize the appeal of GlucoTrack’s non-invasive nature. This will in future be extended to use by children too.
Integrity Applications’ GlucoTrack model DF-F gained CE-Mark approval in June 2013. In March 2014 Integrity Applications received an extension to its CE Mark Approval for 6 month calibration validity of GlucoTrack DF-F calibration. With this extended validity the initial calibration of the GlucoTrack model DF-F device is valid for the entire 6 month lifespan of the Personal Ear Clip (PEC) adding yet another important advantage to using the GlucoTrack DF-F as users are only required to calibrate twice per year when they replace the PEC.
In August 2015 this model received CE Mark approval from Dekra Certification B.V., its Notified Body in the European Union for improvements to the GlucoTrack model DF-F non invasive glucose measurement device.
A further extension of its ISO 13485:2003 certificate and Annex II certification from the European Union (EU) was received in Febuary 2016.
The scope of the certification is design, development, manufacture and service of non-invasive glucose monitoring system for home use. Annex II also addresses quality control systems. The certification allows the company to self certify certain modifications and changes and simplifies some of the reporting to and review by the relevant Notified Body. This can shorten CE-mark review process of future GlucoTrack® Model DF-F enhancements or revisions. As a result of these improvements, the calibration process for the device, which previously required eight finger stick measurements as a reference and took approximately two and half hours to complete, now requires just three finger stick measurements and takes about thirty minutes to complete. In addition, the Notified Body has approved an expansion of the intended use of the GlucoTrack model DF-F to allow for the marketing of the device to the pre-diabetic population.
These improvements are expected to greatly enhance the user experience and allow for doctors and clinicians to calibrate more users, more expeditiously, which is expected to reduce or eliminate any backlog created as new device users await calibration.
GlucoTrack Model DF-F is CE mark approved demonstrated by clinical trials. GlucoTrack Model DF-F is intended for use in non-invasive quantitative spot measurement of glucose, for home-use. The GlucoTrack Model DF-F is intended for use by adults (presently certified for diabetics over 18 years old) type 2 diabetic patients, as well as pre-diabetic patients.
As with all other non capillary blood monitoring devices, medications intake/treatment decisions should not be based only on measurements by GlucoTrack model DF-F.