Horw, Switzerland-based CeQur develops the Simplicity mealtime insulin patch pump system. The wearable, disposable bolus insulin delivery system. It was developed as, essentially, a wearable insulin pen. CeQur began a pilot commercial launch for the FDA-cleared and CE-marked device in early 2021. In April 2021, the company raised $115 million to support that launch and scale up manufacturing.
In 2024, the FDA granted 510(k) clearance for Simplicity for an extended wear duration, expanding from three days to four. Now, the company can offer it for seven continuous days of wear to further reduce the burden of mealtime dosing regimens.
Last week, CeQur announced that the FDA cleared Simplicity for an extended wear time of up to seven days and gave the green light to a new 1-unit (1U) device.
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