The company said Tandem Mobi is now the only tubeless automated insulin delivery system with FDA clearance for up to seven days of wear. Its tubed insulin infusion option had already received clearance.

Tandem plans a full U.S. commercial launch in the first half of next year.

Chief Executive Officer John Sheridan said the clearance for the tubeless cartridge and infusion set would expand the ways people with diabetes can use the company’s Control-IQ+ automated insulin delivery technology.