WaveForm Diabetes Expands Indications for Their Continuous Glucose Monitoring System
Newly approved arm indication and reduced calibrations for the WaveForm Cascade CGM provide greater convenience
Salem, NH March 22, 2022 –AgaMatrix Holdings LLC d/b/a WaveForm Diabetes, a leader in innovative solutions for glucose monitoring, today announces CE Mark approval for two important product improvements to the WaveForm Cascade Continuous Glucose Monitoring (CGM) system. We are pleased to broaden the locations the Cascade CGM sensor can be worn to now include placement on the upper arm. In addition to the new sensor site, improvements to the sensor algorithm have reduced the number of calibrations required for the Cascade system to one every two days.
“We have conducted clinical studies to confirm these two key improvements can be implemented with no clinical difference in the performance of the system,” said Mihailo Rebec, PhD, Chief Technology Officer at WaveForm Diabetes. “We are certain that these system upgrades will add to the user satisfaction of our novel, needle-free CGM, and improve the overall ease of use.”
Clinical studies of the WaveForm Cascade CGM conducted in 2021 demonstrated sensor placement on the upper arm was comparable to the abdomen. By adding the arm indication for use, it provides flexibility for adult and pediatric users to place a sensor in the location that best fits their personal needs.
The WaveForm Cascade CGM system provides an easy, convenient method to continuously monitor glucose for up to 15 days. WaveForm’s long-lasting sensor is virtually painless to insert and comfortable to wear thanks to the unique, needle-free inserter design and specialized sensor polymer coating. Real-time glucose data is transmitted to a smartphone application providing a new reading every minute, glucose trends, and customizable and predictive alerts.
The product will be commercially available in Europe marketed by A. Menarini Diagnostics S.r.l. under the GlucoMen Day name.
For more information about WaveForm Diabetes visit: waveformdiabetes.com
About WaveForm Diabetes (AgaMatrix Holdings, LLC d/b/a WaveForm Diabetes)
WaveForm Diabetes is a medical device company that develops, manufactures, and markets innovative glucose monitoring technology and related software solutions. For over 20 years, we have sought to empower millions of people across the globe to confidently manage their diabetes with our high-performance products.
With 20+ glucose monitoring products and digital applications cleared, we distribute directly in the U.S. and U.K. while also supporting leading Fortune 500 companies with white labeled products. In 2020, we launched our first needle-free, real-time, continuous glucose monitor (CGM) through our distribution partner A. Menarini Diagnostics S.r.l. We are also developing a unique 15-day CGM solution for the market in China, as part of our commercial agreement with Bayer.
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