Le Lézard
Classified in: Health
Subjects: FDA, SBS

SpinTech MRI Earns FDA Clearance for Rapid, Quantitative Brain-Imaging Technology


BINGHAM FARMS, Mich., Aug. 10, 2021 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved SpinTech, Inc.'s latest magnetic resonance imaging software device, STAGE (Strategically Acquired Gradient Echo), a post-processing software platform that enables comprehensive, quantitative brain imaging with enhanced visualization in significantly less time than conventional approaches. STAGE allows MRI technicians to acquire 16 brain imaging contrasts, including 10 enhanced contrast qualitative outputs and 6 quantitative outputs in just 5 minutes on 3T systems. STAGE is cleared for use on both 1.5T and 3T systems across manufacturers, and runs on existing equipment.

"STAGE's FDA clearance is a huge breakthrough for SpinTech," said Ward Detwiler, SpinTech's CEO. "After years of developing and refining the platform through extensive research use, we are incredibly excited to make this game-changing technology available for clinical use in hospitals and imaging centers."

Aside from its enhanced contrast qualitative outputs, STAGE generates quantitative outputs such as T1 & PD maps, and is the first 510(k) cleared product to provide Quantitative Susceptibility Mapping (QSM). Through the company's extensive research partnerships, they have established powerful clinical use cases across numerous diagnostic areas. When interpreted by a trained physician, STAGE-processed images may provide information useful in determining diagnosis for stroke, dementia, Parkinson's, multiple sclerosis, tumors and more.

"Radiologists have long struggled to obtain comprehensive, high-quality clinical data within very constricted scanning windows," said Dr. Mark Haacke, PhD, Founder and Chief Science Officer at SpinTech. "Now, they don't need to choose which sequences to run, just what they are going to examine, as all the data they need has already been collected. On top of the enhanced imaging data, radiology groups will also benefit from increased patient throughput. And, of course, patients experience shorter scan times, so everybody wins."

Hospitals or imaging centers can improve the efficacy of their MR imaging systems, both old and new, without taking machines offline or investing in expensive hardware. STAGE is compatible with nearly any existing MRI, providing standardized image outputs across different manufacturers and enabling more reliable longitudinal comparison across different machines.

"We have seen, pretty consistently, that reimbursement rates are declining while demand for advanced MRI has increased, putting a lot of pressure on imaging groups," said Detwiler. "Technology solutions that improve both cost and workflow efficiency of imaging procedures are paramount to hospitals and imaging centers, and STAGE perfectly fits that bill."

Though STAGE is considered a comprehensive brain imaging post-processing solution, its approval does not extend outside of brain uses and should always be used in combination with at least one other conventional MR acquisition technique. The software is currently in use in over 50 hospitals, imaging centers and research facilities around the globe. In response to growing commercial interest, SpinTech is currently raising additional capital to scale their sales and services and bring a pipeline of future products to market.

About SpinTech
SpinTech produces rapid, quantitative brain imaging software which assists clinicians and researchers in the quick acquisition and interpretation of MRI results. Through enhanced early detection and quantification of biomarkers critical to many neurological disorders, SpinTech technology aids in improving patient outcomes and efficiency, all while reducing costs. Learn more about SpinTech at https://spintechimaging.com

Media Contact:
Erich Boileau
Boileau Communications Management
316231@email4pr.com
616.786.4461

SOURCE SpinTech MRI


These press releases may also interest you

15 oct 2021
Helix BioPharma Corp. ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, announced today that it anticipates the filing of its annual financial...

15 oct 2021
The Centers for Medicare and Medicaid Services (CMS) released its annual quality rankings. For the 2022 plan year, Network Health earned a 5 out of 5-Star Rating from CMS for its Medicare Advantage PPO plans. This is Medicare's highest possible...

15 oct 2021
Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira® (adalimumab). The FDA...

15 oct 2021
Novartis Pharmaceuticals Canada Inc. applauds the government of Quebec's decision to provide public reimbursement for Zolgensma® (onasemnogene abeparvovec)...

15 oct 2021
Worcester Polytechnic Institute (WPI) researcher Loris Fichera has developed a flexible, slimmed-down robotic laser probe for endoscopic larynx surgeries that could reduce recovery time for patients and cut health care spending by shifting procedures...

15 oct 2021
The "Global Industrial Radiography Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Technique (Film-based Radiography and Digital Radiography); End-User Industry" report has been added to ResearchAndMarkets.com's offering. The...



News published on 10 august 2021 at 08:42 and distributed by: