A manufacturer of compact MRI machines that leverage AI to upgrade image quality has received FDA’s blessing to market its technology in the U.S.
Oakland, California-based Promaxo announced the development March 8, saying the agency had granted 510(k) clearance for its product to be used in image-guided prostate procedures such as biopsies.
The company says the system is small enough for installation in urologists’ offices and outpatient surgery suites, no shielding or facility upgrades needed.
The product “incorporates patented technologies to capture, reconstruct and display magnetic resonance images of prostate and surrounding tissues,” Promaxo says. “The proprietary device leverages pre-programmed sequences and artificial intelligence to enhance image quality.”
Announcement here.