FDA Clears BabySat, an At-Home Pulse Oximetry Sock Device for Infants
BabySat is expected to be available by prescription later this year.
BabySat is expected to be available by prescription later this year.
Consumers are being advised to stop using the product immediately.
The device is implanted subcutaneously during an outpatient-compatible procedure.
It was originally approved in 2019 for the treatment of chronic pain.
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 is a wireless remote electrical neuromodulation (REN) device designed to be self-applied to the upper arm.
Dexcom G7 offers new features with a 60% smaller, discreet wearable patch.
Individuals can complete the test in approximately 6 minutes, at which point the test results will be made available to an eye care professional.
Approval was based on a prospective study that included 44 participants who underwent C-section delivery.
In 2 minutes, the portable ATUSA system automatically scans the entire breast volume and provides 3D visualization of the breast tissue.