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August 10, 2021

SpinTech receives 510(k) clearance from US FDA for STAGE imaging software

STAGE collects other conventional images and delivers clinical image data back into radiologists’ workstations.

A portfolio company of Genesis Innovation Group’s cultivate(MD) Capital Fund II LP, SpinTech, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its STAGE magnetic resonance imaging software.

The rapid, multi-contrast imaging method allows scanning of the entire brain in roughly five minutes and unlocks the full potential of MRI.

It provides 16 different types of image contrasts, of which six provide critically important quantitative data.

Effective quantitative data will help in improving diagnostic accuracy and show the changes that take place in a patient’s situation between an initial scan and subsequent examinations.

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

“The FDA clearance allows us to utilise STAGE to help patients in real clinical environments.”

Additionally, the software is capable of gathering other conventional images and delivering clinical image data back into radiologists’ workstations automatically.

A suite of automated diagnostic reports developed by SpinTech continues to grow as improved data and clinical research drive the discovery of new biomarkers, new diagnoses and better conclusions.

cultivate(MD) Capital Funds managing director Matt Ahearn said: “FDA clearance of STAGE sets the foundation for SpinTech’s initial commercialisation and scale.

“STAGE software is an MRI operating system with specialised scanning sequences. STAGE normalises data from all MRI manufacturers and Tesla levels and will provide neuroradiologist’s an un-paralleled platform for diagnostics and reporting.”

SpinTech also developed a suite of automated biomarker detection tools, including reports for Parkinson’s Disease and cerebral microbleed detection.


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