Promaxo Receives 510(k) Clearance from the FDA for its Innovational MRI Platform
The United States Food and Drug Administration (FDA) has granted Promaxo, Inc. (Promaxo) a 510(k) clearance for its revolutionary office-based MRI system. The 510(k) clearance enables practices and hospitals to accurately and seamlessly guide prostate interventions under the Promaxo scanner.
The Promaxo MRI is intended 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.
The Company’s innovative device has a limited fringe field and can be easily installed in an office with no shielding or facility upgrades. The truly open single-sided design, and quiet operation without the need for endorectal coils, leads to a comfortable patient experience. The MRI platform’s unique 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. 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.
“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.”
