CeQur has announced recently that the FDA has granted 510(k) clearance for its Simplicity system for an extended wear duration.
Simplicity, a wearable, disposable bolus insulin delivery system, was developed as, essentially, a wearable insulin pen.
Clearance extends the wear time for the wearable mealtime insulin delivery patch from three to four days. It marks a significant advancement for what the company claims is the longest wearable insulin delivery patch, which provides diabetes discretion, additional convenience and injection-free dosing. Each patch now replaces up to 12 mealtime injections, equalling more than 1,000 fewer injections annually, according to a news release.
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