FDA Clears BabySat, an At-Home Pulse Oximetry Sock Device for Infants
BabySat is expected to be available by prescription later this year.
Diagnosis & Disease Information
Wearable Smart Thermometer Recalled Due to Reports of Injury
Consumers are being advised to stop using the product immediately.
FDA Clears Implantable Shock Absorber to Treat Knee Osteoarthritis
The device is implanted subcutaneously during an outpatient-compatible procedure.
Abbott’s SCS System Cleared for Patients With Painful Diabetic Peripheral Neuropathy
It was originally approved in 2019 for the treatment of chronic pain.
FDA: Early Structural Valve Deterioration Possible With Abbott Trifecta Valves
The Trifecta and Trifecta GT valves are heart valve replacement devices designed to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves.
Nerivio Device Cleared for Migraine Prevention
Nerivio is a wireless remote electrical neuromodulation (REN) device designed to be self-applied to the upper arm.
Dexcom G7 Continuous Glucose Monitoring System Gets FDA Clearance
Dexcom G7 offers new features with a 60% smaller, discreet wearable patch.
FDA Clears At-Home Visual Acuity Testing System
Individuals can complete the test in approximately 6 minutes, at which point the test results will be made available to an eye care professional.
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.
FDA Clears Automated, Wearable 3D Breast Ultrasound Device
In 2 minutes, the portable ATUSA system automatically scans the entire breast volume and provides 3D visualization of the breast tissue.
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