PENS Device Cleared To Treat Pain Following C-Section Delivery
Approval was based on a prospective study that included 44 participants who underwent C-section delivery.
Devices
TMS Device NeuroStar Cleared for Anxious Depression
NeuroStar Advanced Therapy for Mental Health is a transcranial magnetic stimulation system that uses magnetic fields to reignite dormant synapses in the brain.
FDA Clears PENS Device for Pain Related to Diabetic Peripheral Neuropathy
First Relief is a wearable PENS device that is placed behind the ear.
FDA Clears Machine Learning Algorithm to Assist in Heart Murmur Detection
The software uses the Company’s smart stethoscopes to analyze heart sounds, phonocardiogram and electrocardiogram (ECG) signals (when available).
FDA Clears Prescription Digital Therapeutic for Women With Fecal Incontinence
leva Pelvic Health System is a noninvasive digital therapeutic intended to train and strengthen pelvic floor muscles at home.
FDA Clears Barrier-Forming Nasal Spray for Allergic Rhinitis
Bentrio is a drug-free, preservative-free, OTC nasal spray for protection against airborne allergens.
AI Plus Wearable Sensor May Detect Presymptomatic COVID-19
AI algorithm interpreting data from a wearable sensor bracelet that monitors changes in physiologic parameters might allow early detection
Wearable TENS Device Cleared for Fibromyalgia Treatment
The Quell® neuromodulation device (NeuroMetrix) has received the Food and Drug Administration De Novo authorization for use as an aid in reducing the symptoms of fibromyalgia in adults with high pain sensitivity. Quell is a transcutaneous electrical nerve stimulator (TENS) that is worn on the upper calf. The device delivers electrical stimulation to the user…
FDA Warns of Potential Chemical Exposure With Certain Hemodialysis Machines
The source of the chemicals is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines.
FDA Greenlights In Vitro Diagnostic Test to Assess for Alzheimer Disease
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used as an aid in adults 55 years of age and older presenting with cognitive impairment who are being evaluated for Alzheimer disease and other causes of cognitive decline.
