SpinTech’s STAGE Rapid Brain-Imaging Technology Wins FDA 510(k) Clearance

The U.S. Food and Drug Administration approved the new magnetic resonance imaging post-processing software platform developed by SpinTech Inc. to help trained physicians diagnose neurological conditions.

The technology, known as STAGE (Strategically Acquired Gradient Echo), can be integrated into any existing MRI system to rapidly process 16 brain imaging contrasts, including 10 enhanced contrast qualitative outputs and 6 quantitative outputs that can be tracked over time.

“STAGE’s FDA clearance is a huge breakthrough for SpinTech,” CEO Ward Detwiler said in a news release. “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.”

STAGE runs on existing equipment in 1.5T and 3T systems and produces images in about five minutes, reducing brain MRI acquisition times by more than 40%. The software can be used to diagnose conditions such as stroke, dementia, Parkinson's, multiple sclerosis and tumors.

“STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition (e.g., T2 FLAIR),” according to the FDA’s indication for use form.

The software analyzes brain imaging and generates enhanced Tl 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. STAGE also generates Tl and proton density (PD) maps and is the first product to provide Quantitative Susceptibility Mapping (QSM).

It is substantially similar to SyMRI software and consists of a dedicated medical grade computer that receives DICOM (Digital Imaging Communications in Medicine) data from a specific MRI 3D GRE scan protocol and then outputs numerous DICOM datasets with different types of contrast.

“Radiologists have long struggled to obtain comprehensive, high-quality clinical data within very constricted scanning windows,” Mark Maacke, PhD, founder and chief science officer of SpinTech said in the statement. “Now, they don’t need to choose which sequences to run, just what they are going to examine, as well as 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.”

The new technology will allow practices to improve efficiencies and adapt to declining reimbursements.

STAGE is in use in more than 50 hospitals, imaging centers and research facilities around the world. SpinTech is a Detroit, Michigan-based startup. It is raising capital to expand.

SpinTech recently acquired Magnetic Resonance Innovations Inc. (MR Innovations), including engineers and physicists along with 10 patents, over 300 published papers and a network of more than 50 global collaborators. The deal will allow the company to provide fully-integrated research and development.

Detwiler introduced STAGE during a presentation at the American Society of Neuroradiology in May.

Several new developments in brain imaging technology have emerged in recent years, including MRI-guided focused ultrasound and 7T MRI, which were featured at last year’s Radiological Society of North America annual meeting.

Two recent studies demonstrated how 3D amplified MRI can produce real-time brain movement in detail, allowing physician to non-invasively see brain disorders. Another recent study explored the use of an artificial intelligence-based system to automate MRI interpretation, quickly categorizing brain MRI results into “likely normal” and “likely abnormal.”