It has succeeded on multiple fronts, including:
- AAMI compliant. AAMI has developed a test standard — EC-12 — that is basically geared for hydrogel. OMNI-WAVE™ passed EC-12 tests with ease.
- Independent medical studies. According to two UMASS Medical School clinical trials, OMNI-WAVE™ electrodes were compared to Kendall ECG readouts and DOT ECG readouts and found to be essentially the same.
- ISO 10993-10 approved. The product is ISO 10993-10 approved for sensitization and irritation.
In addition to the testing standards, OMNI-WAVE™ has over 13 US patents and 90 patents worldwide.
INNOVIZE CONDUCTS A HARD AND SOFT COST COMPARISON
Innovize, a contract manufacturing company with a focus on stick-to-skin medical devices, conducted a hard and soft cost comparison analysis between OMNI-WAVE™ and traditional hydrogel materials.
They found that while the cost of the materials are comparable, there were several advantages to OMNI-WAVE™ when costing products for customers:
Here are more details on the comparison.
ROLLOUT GEARED TO THE PACE OF DISRUPTION
When you innovate to the degree that FLEXcon has with OMNI-WAVE™, you open up a whole new set of possibilities. But despite all the potential to replace hydrogel, FLEXcon understands that an application as potentially disruptive as OMNI-WAVE™ won’t be implemented overnight.
That’s why FLEXcon is rolling it out as a wearable product for up to 3 day use. This is more in-line with the trend to use wearable devices that communicate data to the cloud, and it’s a space in need of more innovative technologies.
As OMNI-WAVE™ becomes more widely used, FLEXcon hopes they’ll become more widely accepted in more established use cases.
But if you’re a converter or OEM looking for immediate relief from hydrogels production woes, there’s no reason why you shouldn’t be one of the first to trigger the disruption. Based on the data, medical practitioners and patients will thank you for it.
Learn more about OMNI-WAVE™