Health / Investing
Add as a preferred source on GoogleAt 9:59 a.m. ET (14:59 UTC), Tandem shares traded at $19.62, up $2.11.
Tandem Diabetes Care shares rose 12% Friday morning, while the company said the U.S. Food and Drug Administration cleared a Mobi insulin pump configuration that operates without tubing.
The shares were quoted at $19.62 at 9:59 a.m. ET (14:59 UTC), reflecting a $2.11 gain and a 12% advance.
Tandem said the FDA used its 510(k) pathway to clear the configuration.
Medline reported two deaths and 16 serious injuries associated with the product issues as of Oct. 20. The FDA says covered products must be removed from use or sale unless corrected.
The government accepted 44 recommendations on AI in health care, and draft guidance on changes to medical devices is due by December 2026.
Flo said the audit found no major issues. Scarlet says the certification concerns a management system, not whether a specific product meets medical-device requirements.
