Hyperfine gains FDA clearance for deep learning-based image reconstruction tool
Portable MRI creator Hyperfine has won federal clearance for its novel deep learning-based image reconstruction tool, the company announced Monday.
The U.S. Food and Drug Administration 510(k) greenlight will further enhance the quality of scans produced using Hyperfine’s flagship Swoop MRI machine, company officials said. That includes superior T1, T2 and FLAIR images.
Providers armed with these enhanced exams can diagnose patients quicker and more accurately.
“With the integration of deep learning-based image reconstruction, clinicians can now visualize anatomy and pathology more clearly and with increased confidence enabling diagnosis in a more expeditious fashion, critical for the treatment of acute neurological conditions,” Fady Charbel, MD, head of the Department of Neurosurgery at the University of Illinois of Chicago, said Nov. 29.
Back in January, Hyperfine received FDA clearance for its artificial intelligence application that interprets brain MRI scans. The tool automatically measures ventricular volume, midline shift and other important neurological features.
The Guilford, Connecticut, company recently welcomed new leadership, including former Apple guru Dave Scott who took over as CEO in June. Shortly after the hire, Hyperfine combined with Liminal Sciences and went public on the Nasdaq as a special-purpose acquisition company valued at $580 million.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.