GlySens has received approval from the US Food and Drug Administration (FDA) to expand its current human clinical evaluation of its fully implantable ICGM continuous glucose monitoring system.
The company has obtained the approval to extend the current clinical evaluation of the ICGM system from the originally approved six-month duration to the system’s commercially-intended operational duration of twelve months.
GlySens co-founder and CTO Dr Joseph Lucisano said: "We very much appreciate the timely review and approval by FDA of our request to extend the duration of this clinical evaluation, and are grateful for their thoughtful and collaborative working approach."
GlySens president and CEO William Markle said: "This extension approval is excellent news and puts us in the enviable position to evaluate our CGM solution across its intended use duration and in real-life conditions."
The GlySens ICGM system is claimed to be the world’s first fully implanted CGM system to show 18-month in vivo performance in a preclinical setting.
GlySens system’s key attributes comprise fully implanted sensor that enables an essentially undisturbed body image and an expected need for only infrequent calibrations, currently anticipated to be no more frequently than twice monthly.
The current study is being carried out under an FDA-approved IDE in the greater San Diego area.