FDA Clears Promaxo’s Magnetic Resonance Imaging Platform for Office Settings
The FDA has granted Promaxo 510(k) marketing clearance for its office-based magnetic resonance imaging (MRI) system, the Promaxo MRI.
The system is now cleared for use in hospitals and physicians’ offices for guiding prostate interventions using its scanner. It is intended for use by urologists and interventional/urologic radiologists for surgical localization of prostatic lesions in the office or outpatient surgical settings.
The device is easy to install in an office because it does not need special shielding or facility upgrades, and it does not require the use of endorectal coils in patients during MRI scans.