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SpinTech MRI Announces FDA 510(k) Clearance and Availability for STAGE 2.0 with CROWN Noise Reduction for Faster Brain Scans and Greater Image Clarity


News provided by

SpinTech MRI, Inc.

Nov 18, 2022, 07:00 ET

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STAGE with CROWN accelerates MRI speed by 30%, improves image details for diagnostic confidence, and expands time for exams by 90+ minutes per scanner per day to increase revenue

BINGHAM FARMS, Mich., Nov. 18, 2022 /PRNewswire-PRWeb/ -- SpinTech MRI, creators of the STAGE™ (STrategically Acquired Gradient Echo) quantitative magnetic resonance imaging (MRI) software platform, today announced FDA 510(k) clearance for its new STAGE 2.0 software with CROWN™ (Constrained Reduction Of White Noise) technology. STAGE 2.0 with CROWN reduces brain scan times by 30% while significantly increasing image clarity, expanding patient access to neurological imaging for Parkinson's, Alzheimer's and other diseases, and supporting health system revenue growth.

SpinTech MRI is highlighting STAGE 2.0 with CROWN at the RSNA conference in Chicago, Nov. 27 to Dec. 1, in booth #5123 in the McCormick Place South Hall.

"STAGE uses proven physics science to provide a cost-effective means for improving MRI efficiency, image quality and financial performance at most facilities."

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STAGE 2.0 with CROWN uses the company's deep expertise in MRI physics to accelerate acquisition and processing of 1.5T and 3T output while reducing image noise and improving signal-to-noise ratio. Compared to fast-scanning techniques that rely on AI to interpolate values from subsampled data and reconstruct image details, STAGE 2.0 with CROWN uses fully sampled data to improve image quality and grey matter/white matter differentiation.

In addition to shorter acquisition times for multi-contrast scans, increased image clarity enables faster, more efficient interpretation and greater diagnostic confidence. It also produces susceptibility weighted image maps for faster detection of disease biomarkers, enhanced precision for surgical placement of Deep Brain Stimulation (DBS) devices, and shorter scans for pediatric patients without the need for sedation.
Health systems are exploring ways to improve MRI efficiency and utilization in response to growing demand for advanced diagnostic imaging and increasing financial pressures. For example, MRI is a primary diagnostic technology for more than 30 percent of Americans aged 65 and older today who are experiencing dementia or mild cognitive impairment. At the same time, burnout among radiologists is increasing and imaging reimbursements are declining.

In testing on 6 different MRI systems at a busy U.S. health system with high neuroradiology volumes, multi-contrast scans processed using STAGE 2.0 with CROWN averaged 30% faster than conventional protocols. The time savings created 3 to 4 new scanning slots per scanner per day and projected annual revenue increases of more than $240,000 for each 1.5T system and $320,000 for each 3T system.

"The need to increase MRI speed while maintaining output quality is driving imaging centers to try a variety of approaches from MRI suite redesign to AI-augmented interpretation tools," said Dr. James Backstrom, a neuroradiologist with over 28 years of experience. "While many of those options are limited by tight budgets or the need to validate new technology, STAGE uses proven physics science to provide a cost-effective means for improving MRI efficiency, image quality and financial performance at most facilities."

STAGE 2.0 with CROWN enables near-3T-quality output from 1.5T scanners to improve quality and throughout without the need to purchase expensive higher-field strength magnets. CROWN also can further improve imaging times by leveraging fast-scanning techniques available on many new scanners. In addition, STAGE produces standardized, cross-platform output to support longitudinal patient monitoring and the creation of training data sets for AI models.

"STAGE provides radiologists, neurologists and health systems a comprehensive and practical solution for improving MRI speed, diagnostic clarity and financial performance," said SpinTech MRI President and CEO Karen Holzberger. "Our CROWN technology expands those benefits by applying innovations in trusted MRI science within existing clinical workflows and across different scanner manufacturers, models and field strengths. Ultimately, the STAGE platform solves for the top priorities of improving patient experiences and outcomes, reducing provider burnout and supporting long-term financial stability for health systems."

About STAGE
STAGETM is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems, utilizing magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of T1, R2, and proton density (PD). STAGE generates standardized image data regardless of scanner brand or model for patient monitoring and data-sharing between facilities, and to inform longitudinal and population health studies.

About SpinTech MRI
SpinTech MRI was founded 2017 by internationally recognized MRI industry professionals to transform quantitative MRI imaging with advanced data acquisition and visualization tools that are easy to deploy and practical for everyday clinical use. The company's STAGE software platform significantly enhances MRI efficiency and clinical value for neurologists, radiologists, and other physicians to improve quality of life and care outcomes for patients with Parkinson's, Alzheimer's, dementia, multiple sclerosis, traumatic brain injury (TBI), stroke, cerebral microbleeds (CMB) and other neurological diseases.

Media Contact

Karen Holzberger, SpinTech MRI, Inc., 1 248-712-6789, [email protected]

SOURCE SpinTech MRI, Inc.

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