INBRAIN Neuroelectronics Receives FDA Breakthrough Device Designation for Graphene-Based Intelligent Network Modulation Platform
First-of-a-kind system designed to offer new treatment option for patients with Parkinson’s disease
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FDA
Carlsmed Receives FDA Breakthrough Device Designation for Aprevo® Technology
Carlsmed’s aprevo® device for the treatment of cervical spine disease is anticipated to be launched in the U.S. in 2025
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ChoiceSpine Receives FDA Approval for Blackhawk® Ti 3D Printed Cervical Spacer System with Standalone Indication
Featuring BioBond® 3D Printed Titanium porous structure, Blackhawk® Ti is available in two anatomical footprints with significant room for graft material and large lateral windows for enhanced visual confirmation
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AIRAmed Receives FDA Approval for AIRAscore Brain Volumetry Software
Novel Technology Aids Physicians in Early Detection of Alzheimer’s and Other Dementias
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SpectraWAVE Receives FDA Approval for Product Enhancements to the HyperVue™ Imaging System
Next Generation DeepOCT™ and Near Infrared Spectroscopy Intravascular Imaging System Now Includes Expanded Toolkit to Optimize Coronary Stent Placement in the Cardiac Catheterization Lab
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B. Braun Receives FDA Approval for AQUAbase® nX Reverse Osmosis System
A Customizable Dialysis Solution that Disinfects without Chemicals
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SmartCardia Receives FDA Approval for its 7-Lead ECG Real-Time Patch and Cloud Platform
that is easy to wear, wireless, waterproof and can be used for continuous monitoring for up to 14 days
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Wellysis Receives FDA Approval for S-Patch Ex Wearable ECG Patch
Embedded with Samsung’s Next-Generation bio-processor proven to capture world’s most accurate ECG waveforms
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Attune Medical Receives FDA Approval for ensoETM Device
Receiving ensoETM™ Granted FDA De Novo Marketing Authorization to Reduce the Likelihood of Ablation-related Esophageal Injury Resulting from Radiofrequency Cardiac Ablation Procedures
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Insight Medbotics Receives FDA Approval for IGAR MRI-Compatible Robot
The IGAR system is the first and only robotic guidance and placement system cleared to work inside an MRI bore, one of the most challenging hospital environments
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