Abbott landed a surprise US FDA approval for the FreeStyle Libre 3 glucose monitoring system. Also this week: updated guidance documents on software (UK) and angioplasty catheters (US), FDA clearances for Candesant and Moximed, new regulatory requirements for spinal spheres, and a warning on Halyard masks.
The US Food and Drug Administration has approved a new standalone reader device for Abbott’s FreeStyle Libre 3 integrated glucose monitoring system, the company announced on 14 April.
The FreeStyle Libre 3 reader offers an alternative to the FreeStyle Libre smartphone app. It connects to the sensor on...