MSKai Spine Imaging Software Receives FDA 510(k) Clearance for Clinical Use
Advanced software tool supports consistent, objective evaluation of lumbar spine MRI scans.
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Advanced software tool supports consistent, objective evaluation of lumbar spine MRI scans.
With this approval, ABO Holdings is now operating all six plasma collection centers—two each in California, Utah, and New Jersey.
This transformative device advances safety and efficiency in drug preparation, underscoring the startup’s journey from solo founder to FDA-cleared innovator.
“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Dan Levangie, Chairman & CEO of CereVasc, Inc. “We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.”
Reflects the potential of EvoLiver test to improve early liver cancer detection among high-risk patients
First FDA clearance for Nanox.ARC X to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal and paranasal indications. The enhanced imaging system features sleek design with smaller footprint; simplified ‘plug and play’ installation process and the system design enables software upgrades and new capabilities to be added remotely following future regulatory clearances