Ready for commercial distribution, the first single-sided MRI, cleared for office setting, will be available in the United States.
Oakland, CA (March 8th, 2021) — The United States Food and Drug Administration (FDA) has granted Promaxo Holdings, Inc. a 510(k) clearance for its revolutionary office-based MRI system. The clearance enables practices and hospitals to accurately 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 MRI guidance in an office or outpatient surgical setting. Multiple validation studies have demonstrated the platform to be safe, accurate and effective. The device is being used under an investigational device exemption to perform targeted prostate biopsies at Mississippi Urology.
The innovative device has a limited fringe field and can be installed in an office without shielding or facility upgrades. The open single-sided design and quiet operation without endorectal coils provides a comfortable patient experience. The MRI platform uses permanent magnets arranged to provide uniform magnetic field within the field of view, incorporating patented technologies and artificial intelligence to enhance image quality.
Dr. Amit Vohra, Founder and CEO, stated: “Every decision made since Promaxo’s inception has been with the patient and provider in mind.”
About Promaxo: Founded by entrepreneurs and healthcare innovators in Oakland, California, and backed by over 60 patents, Promaxo develops minimally invasive MRI and robotic platforms for improving medical imaging and interventions.