Promaxo gets FDA clearance for office-based MRI scanner

By staff writers

March 8, 2021 -- Medical imaging, robotics, and artificial intelligence (AI) technology firm Promaxo has received clearance from the U.S. Food and Drug Administration (FDA) for its office-based Promaxo MRI scanner.

The scanner was designed for urologists and interventional/urologic radiologists to conduct surgical localization of prostate lesions under MRI guidance in office or outpatient surgical settings. The scanner uses an open single-side design that enables easier access during procedures.

Promaxo's single-side MRI system has been cleared for use in medical offices. Image courtesy of Promaxo.

The Promaxo scanner has a limited fringe field and can be installed in an office with no shielding required. What's more, the scanner uses the company's inherent z-gradient technology and array of permanent magnets to provide a uniform in-plane magnetic field in the field of view, according to the company.

Promaxo said the scanner is being used under an investigational device exemption to conduct targeted prostate biopsies at Mississippi Urology Clinic in Jackson, MS.

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