SpinTech's brain imaging software nabs FDA clearance to speed diagnosis of Parkinson's, MS and more

In its mission to improve MRI technology to diagnose fast-progressing neurological conditions more quickly and accurately than before, SpinTech opted not to completely reinvent the wheel. Instead, the startup developed a software platform that can integrate directly into any existing MRI system to churn out high-resolution imaging data.

That strategy worked: SpinTech’s STAGE software—named for the “strategically acquired gradient echo” MRI sequence on which it’s based—has recently received 510(k) clearance from the FDA.

With the regulatory green light, SpinTech will be able to bring its software to radiologists all over the U.S., helping them more easily pinpoint biomarkers of neurological conditions like Parkinson’s disease, multiple sclerosis, stroke, cancer and more.

RELATED: In rare double-SPAC deal, Hyperfine picks up brain-sensing tech company as it goes public

It does so by producing 16 separate outputs, including 10 high-contrast qualitative images of the brain and six that provide quantitative measurements that can be tracked over time to more closely monitor changes in a patient’s condition.

Those images—plus a comprehensive report detailing the data—take only about five minutes for STAGE to produce. According to the company, that slashes standard brain imaging processing time by an average of 40%.

“STAGE’s novel acquisition technique and post-processing software, which grew from the world’s top MRI research groups, is designed to enhance visualization of biomarkers that couldn’t be seen in the brain before while improving throughput and accuracy, making it a significant advancement in imaging,” said SpinTech CEO Ward Detwiler.

“Providing research support is in our DNA. Now, looking at practical applications, we will show how to tap the full potential of this product to help radiologists unlock new information from the brain,” Detwiler continued.

RELATED: Philips puts forward new MRI method enabling total heart scans in less than one minute

That includes SpinTech’s work to automate several steps of the biomarker detection process. So far, the company has developed tools that analyze the 16 outputs to automatically detect microbleeds and measure a patient’s neuromelanin content, helping radiologists diagnose cerebral microbleeds and Parkinson’s disease, respectively.

The Michigan-based startup is also exploring whether the STAGE software could be used outside of the brain to improve disease detection and diagnosis in other parts of the body.

Those projects are backed by SpinTech’s lifetime funding of about $11 million in research grants and venture capital from backers like Genesis Innovation Group’s Cultivate (MD) Capital Fund II.

SpinTech also recently expanded its technological reach with the acquisition of Magnetic Resonance Innovations earlier this year. Through that buyout, MR Innovations’ more than 20 years of developments in MRI research software and imaging methods were brought under the SpinTech umbrella, allowing it to leapfrog ahead in the R&D process and speed up its work in detecting disease in the brain and beyond.