TANDEM DIABETES CARE INC (TNDM): Form 8-K filed 2026-11-13
- Accepted by EDGAR
- 2026-11-13 08:35 ET
- Event date
- 2026-11-12
- Accession no.
- 0001438133-26-000148
- Original filing
- SEC EDGAR filing index
AI summary of the filing text. It can contain mistakes; the original filing is authoritative.
Tandem Diabetes Care receives FDA clearance for Tandem Mobi tubeless option
Tandem Diabetes Care received FDA 510(k) clearance on November 12, 2026, for a tubeless Tandem Mobi option. The tubeless infusion set is cleared for up to 7 days of wear, while the cartridge is cleared for 3 days of use. Full commercial launch of the new cartridge and infusion set in the United States is planned for the first half of 2027.
- FDA 510(k) clearance was received on November 12, 2026.
- A new tubeless cartridge and infusion set converts the current Tandem Mobi pump into a tubeless device.
- The tubeless infusion set is cleared for up to 7 days of wear; the cartridge is cleared for 3 days of use.
- Full U.S. commercial launch is planned for the first half of 2027.
regulatoryproduct
Items reported
- Item 8.01: Other Events
A voluntary disclosure of an event the company considers important to security holders that no other Item covers, such as a dividend declaration, a buyback program, litigation updates or product news.
Documents
| Type | Description | Document |
|---|---|---|
| 8-K | 8-K | tndm-20261112.htm |
The summary above was generated by AI from the filing text and checked automatically against it. Read the original documents on SEC EDGAR. How to read an 8-K.