Abbott’s SCS System Cleared for Patients With Painful Diabetic Peripheral Neuropathy
It was originally approved in 2019 for the treatment of chronic pain.
Diagnosis & Disease Information
Dexcom G7 Continuous Glucose Monitoring System Gets FDA Clearance
Dexcom G7 offers new features with a 60% smaller, discreet wearable patch.
Omnipod 5 Users – Safety Issue Prompts Urgent Communication
The correction is related to the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) melting, deforming, or discoloring.
FibroLux Laser Therapy Cleared to Treat Pain Associated With Fibromyalgia
The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study.
PENS Device Cleared to Treat Pain Following Cardiac Surgery
Approval was based on a prospective study that evaluated the effectiveness of the Primary Relief device in 60 patients who underwent cardiac surgery.
FDA Warns of Cybersecurity Risk With Certain Medtronic Insulin Pumps
Equipment issue may allow someone to break in and cause the pump to deliver too much or too little insulin to the patient
MPR Weekly Dose Podcast #130
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.
Philips Recalls Certain CPAP, Bi-Level PAP Therapy Masks Due to Safety Concerns
According to the FDA, the magnets from the mask can “potentially affect the functioning of or cause movement of certain implanted metallic medical devices.”
FDA Clears SAINT Neuromodulation System for Major Depressive Disorder
The SAINT Neuromodulation System is an integrated hardware, software, and cloud-computing system that uses structural and functional MRI.
Vibrant, a Drug-Free Treatment for Chronic Idiopathic Constipation, Gets FDA Clearance
The marketing authorization was supported by data from a pivotal clinical trial in 312 patients with chronic idiopathic constipation.
