Abbott’s SCS System Cleared for Patients With Painful Diabetic Peripheral Neuropathy
It was originally approved in 2019 for the treatment of chronic pain.
It was originally approved in 2019 for the treatment of chronic pain.
Dexcom G7 offers new features with a 60% smaller, discreet wearable patch.
The correction is related to the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) melting, deforming, or discoloring.
The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study.
Approval was based on a prospective study that evaluated the effectiveness of the Primary Relief device in 60 patients who underwent cardiac surgery.
Equipment issue may allow someone to break in and cause the pump to deliver too much or too little insulin to the patient
This week, news of the FDA’s vote on AMX0035, the novel ALS treatment; CPAP and BiPAP device recalls; Orphan Drug designation for a novel CRISPR therapy; Imfinzi gains new approval; and Spevigo is approved for pustular psoriasis flares.
According to the FDA, the magnets from the mask can “potentially affect the functioning of or cause movement of certain implanted metallic medical devices.”
The SAINT Neuromodulation System is an integrated hardware, software, and cloud-computing system that uses structural and functional MRI.
The marketing authorization was supported by data from a pivotal clinical trial in 312 patients with chronic idiopathic constipation.