STAGE also collects other conventional images, with enhanced contrast, automatically delivering clinical image data back into the radiologists' workstations
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Genesis Innovation Group’s cultivate(MD) Capital Fund II LP, a fund focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, SpinTech, has received FDA 510(k) clearance for their STAGETM magnetic resonance imaging software.
SpinTech is a privately-held medical device company at the frontier of brain imaging and MRI technology that has developed a comprehensive software platform for improving the diagnosis and treatment of a wide range of neurological conditions.
Radiologists face the challenge of accurately detecting the biomarkers critical for proper diagnosis and treatment of brain disorders in a meaningful timeframe and within clinical workflows. STAGE is a powerful, rapid, multi-contrast imaging method that allows scanning the entire brain in roughly five minutes, unlocking the full potential of MRI. STAGE provides sixteen different types of image contrasts, six of which are the critically important quantitative data. Effective quantitative data helps improve diagnostic accuracy and will show changes in a patient’s situation between an initial scan and subsequent examinations.
STAGE also collects other conventional images, with enhanced contrast, automatically delivering clinical image data back into the radiologists’ workstations. On top of this data, SpinTech has developed a suite of automated diagnostic reports, which continues to grow as improved data and clinical research drive the discovery of new biomarkers, new diagnoses and better conclusions. A more conclusive diagnosis leads to more effective treatment for the patient.
Ward Detweiler, President and CEO of SpinTech said, “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. The FDA Clearance allows us to utilize STAGE to help patients in real clinical environments.”
Matt Ahearn, Managing Director, cultivate(MD) Capital Funds said, “FDA clearance of STAGE sets the foundation for SpinTech’s initial commercialization and scale. STAGE software is an MRI operating system with specialized scanning sequences. STAGE normalizes data from all MRI manufacturers and Tesla levels and will provide neuroradiologist’s an un-paralleled platform for diagnostics and reporting.”
The company, which has decades of technical and thought leadership in the field of MRI and a global network of clinical partners, has also developed a suite of automated biomarker detection tools, including reports for Parkinson’s Disease and cerebral microbleed detection and is exploring utilization of the technology in other parts of the anatomy.
Mr. Detweiler added, “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.”
Source: Company Press Release