510(k) clearance has been awarded to artificial intelligence-based tool designed to accelerate respiratory disease diagnosis.
Nines Radiology announced Tuesday it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new lung nodule measurement tool, NinesMeasure™.
Built using artificial intelligence (AI), this tool is designed to facilitate rapid diagnosis of respiratory conditions. Its development is also unique, said company officials.
“To our knowledge, NinesMeasure is the only lung nodule measurement tool cleared by the FDA that was developed by a combined team of radiologists and engineers collaborating every day,” said Michael Kelleher, M.D., Nines Radiology president, noting that radiologists are paired with house engineers for development. “This advanced tool can significantly reduce the amount of time our radiologists spend measuring pulmonary nodules, improving time to diagnosis for patients without rushing our radiologists.”
This marks the Silicon Valley-based company’s second FDA clearance in 10 months, following its AI-based technology that triages mass effect conditions and intracranial hemorrhages.
According to company data, NinesMeasure is designed to help radiologists measure nodules along the long and short axes quickly and with high accuracy. It can also help providers address inter-study consistency throughout a patient’s treatment.
With this clearance, Nines also augmented its product offerings that have led to significant improvements in non-diagnostic workflow and fewer distractions by administrative tasks, the company said. On average, they said, the company’s focus on improving clinical workflow has led to a 40-percent gain in efficiency for radiology customers.
For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-Newsletter here.