March 02, 2022
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Rivas is the vp and normal supervisor of hospital at Dexcom. Philis-Tsimikas experiences advisory board charges paid to her establishment by Dexcom.
The FDA has granted breakthrough machine designation for using Dexcom’s steady glucose monitoring system within the hospital setting, in keeping with an trade press launch.
The breakthrough machine designation comes practically 2 years after the FDA notified Dexcom it could train enforcement discretion and allow using its CGM system in treating sufferers in hospital settings and different well being care amenities to help COVID-19-related efforts throughout the pandemic.
“Throughout the COVID-19 pandemic, the FDA allowed Dexcom CGM for use in hospitals to assist well being care suppliers handle affected person glucose ranges,” Gil Rivas, vp and normal supervisor of hospital at Dexcom, mentioned in a press launch. “What began as a response throughout the pandemic has proven promise as a greater various to finger stick blood glucose assessments with higher high quality of care and affected person satisfaction.”
Dexcom’s CGM makes use of a small, wearable sensor and transmitter to constantly measure and ship glucose degree to a wise machine, offering real-time glucose knowledge. The system has customizable alerts and alarms for high and low blood glucose occasions.
The FDA’s breakthrough machine designation expedites the event and regulatory overview of medical gadgets with the potential for more practical remedy or prognosis of life-threatening or irreversibly debilitating ailments. Producers of breakthrough gadgets work together with the FDA to handle matters in a well timed method.
“In our intensive use of Dexcom CGM in our hospitals as a part of exploratory research over the past 7 years, greater than 800 of these sufferers handled throughout the pandemic, we now have discovered that the machine improves glucose management with none elevated threat in hypoglycemia,” Athena Philis-Tsimikas, MD, an endocrinologist and company vp for the Scripps Whittier Diabetes Institute in San Diego. “Breakthrough machine designation from the FDA could possibly be transformative for utilizing CGM for in-patient care in hospitals.”