The US Food and Drug Administration (FDA) has granted 510(k) approval for STAGE (Strategically acquired gradient echo), the latest magnetic resonance imaging (MRI) technology developed by SpinTech. STAGE is a post-processing software platform that enables comprehensive, quantitative brain imaging with enhanced visualisation in significantly less time than conventional approaches.
According to a company press release, STAGE allows MRI technicians to acquire 16 brain-imaging contrasts, including 10 enhanced contrast qualitative outputs and six quantitative outputs, in just five minutes on 3T systems. STAGE is cleared for use on both 1.5T and 3T MRI systems across manufacturers, and runs on existing equipment.
“STAGE’s FDA clearance is a huge breakthrough for SpinTech,” said SpinTech CEO Ward Detwiler. “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 centres.”
Aside from its enhanced-contrast qualitative outputs, STAGE generates quantitative outputs like T1 and proton density (PD) maps, and is the first 510(k)-cleared product to provide quantitative susceptibility mapping (QSM). Through its extensive research partnerships, SpinTech claims to 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 disease, multiple sclerosis, tumors and more, the release adds.
“Radiologists have long struggled to obtain comprehensive, high-quality clinical data within very constricted scanning windows,” said Mark Haacke, founder and chief science officer at SpinTech. “Now, they do not need to choose which sequences to run—just what they are going to examine, as all the data they need have 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 centres can improve the efficacy of their MRI systems, both old and new, without taking machines offline or investing in expensive hardware, SpinTech claims—as STAGE is compatible with nearly any existing MRI, providing standardised 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,” added Detwiler. “Technology solutions that improve both cost and workflow efficiency of imaging procedures are paramount to hospitals and imaging centres, 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 MRI acquisition technique, the release concludes. The software is currently in use in more than 50 hospitals, imaging centres and research facilities around the globe. In response to growing commercial interest, SpinTech is currently raising additional capital to scale its sales and services, and bring a pipeline of future products to market.
