Single-sided MRI Platform Gets FDA Nod

A new office-based, single-sided MRI platform by Proxamo, Inc. designed to guide prostate interventions has received US FDA 510(k) clearance. The Proxamo MRI is for urologists and interventional/urologic radiologists to perform surgical localization of prostatic lesions under Promaxo MRI guidance in an office or outpatient surgical setting.

Multiple validation studies have demonstrated the first-of-its-kind platform technology to be safe, accurate and effective. The Promaxo MR imager is currently being used under an investigational device exemption to perform targeted prostate biopsies at Mississippi Urology.

“Every decision made since Promaxo’s inception has been with the patient and provider in mind, to find ways that our technology can both make lives easier and improve treatment outcomes,” said Dr. Amit Vohra, Founder and CEO of Promaxo. “We are looking forward to the next phase in our evolution as we begin to work with urologists and interventional radiologists to install and embrace our MRI product within their practices.”

The Promaxo MR imager has a limited fringe field and can be installed in an office with no shielding or facility upgrades. The open, single-sided system does not require the use of endorectal coils.  The MRI platform’s configuration is built upon an inherent z-gradient and array of permanent magnets arranged to provide a uniform in-plane magnetic field within the field of view. It has a small form factor and a low magnetic field strength in the imaging region, allowing for fast RF pulses and strong field gradients without causing peripheral nerve stimulation. Further, the tissue heating is minimal and well below the safety thresholds.

The product incorporates patented technologies to capture, reconstruct and display magnetic resonance images of prostate and surrounding tissues. The proprietary device leverages pre-programmed sequences and artificial intelligence to enhance image quality.