Category:
FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Cionic’s Neural Sleeve Granted FDA Clearance
The lightweight and durable Neural Sleeve is designed to help people walk, a fundamental activity key to independent living, however, Cionic has built their platform from the ground up to enable solutions across the mobility spectrum. Cionic completed human factors and efficacy testing and submitted the Neural Sleeve for FDA clearance in November 2021.
SurGenTec Launches ION Screw, Smallest Posterior Spinal Fixation Implant, to Market After Receiving FDA Clearance
The patented ION implant is the smallest posterior fixation implant cleared for spine surgery – smaller than the size of a dime – and can be placed through a tiny incision with minimal tissue disruption.
GLEAMER Receives FDA Clearance for BoneView® AI Software-Helps to Detect and Localize Fractures
BoneView detects fractures in X-ray images and submits them to radiologists for final validation, providing healthcare professionals with a safe, reliable, time-saving and user-friendly tool.
Medtronic receives FDA approval for InterStim X™ system, the next generation of the most personalized sacral nerve stimulation therapy for bladder and bowel control
Medtronic notes new InterStim X™ system provides 10 to 15 years of battery life without the need to recharge
CardioMEMS HF System Receives FDA Approval to Support Patients Battling Earlier-Stage Heart Failure
"As the number one cause for hospitalizations in people age 65 and over, heart failure is its own pandemic in the United States," said J. Thomas Heywood, M.D., director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic in La Jolla, Calif. "Utilizing the CardioMEMS HF System to monitor for signs of worsening heart failure has been shown repeatedly to reduce hospitalizations for patients with later-stage heart disease."
Medtronic Receives FDA Expanded Approval for Cardiac Cryoablation Catheters for Pediatric Treatment of a Common Heart Rhythm Condition
AVNRT is the most common form of supraventricular tachycardia (SVT), and is a life-threatening abnormal heart rhythm, with 89,000 cases each year and growing.
Eversense E3 CGM System for Up to 6 Months Receives FDA Approval Reports Senseonics
Physicians, nurse practitioners, and physician assistants interested in offering the Eversense CGM System for their patients can sign up
Magnifico Open MRI System Receives FDA Approval
The Magnifico Open MRI is equipped with new advanced technologies that offer versatility in imaging across a wide range of clinical applications
Smart Noise Cancellation by Carestream Receives FDA 510(k) Clearance
Smart Noise Cancellation (SNC) technology by Carestream has received FDA 510(k) Clearance for its dose reduction capability.
The artificial intelligence (AI)-based feature allows a user...
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