Harmonus receives FDA clearance for ProBx software

Harmonus (Boston) announced that it has received FDA 510(k) clearance for its ProBx software for MRI-guided prostate interventions.

The software is a solution to a problem of suboptimal prostate cancer diagnoses and provides doctors and patients with better options to diagnose and treat prostate cancer.

ProBx software precisely and efficiently targets and confirms suspicious lesions, unlike traditional MRI-guided biopsies. It also creates a detailed record of sampling locations to allow the doctor to continuously watch and treat lesions. The software acts as a kiosk that is connected to an MRI console. It receives DICOM images and can display them to the doctors and patients through 2D and 3D visualization. ProBx software is also designed to make the procedure easier by leading doctors through the appropriate workflow steps with the option to backtrack if needed.

“One in nine men will receive a diagnosis of prostate cancer in their lifetime, according to the American Cancer Society” said Harmonus CEO Nicole Mauro in a press release. “It is the second leading cause of cancer death among men.” Almost all prostate biopsies are guided by trans-rectal ultrasound (TRUS), which has limited accuracy and can cause serious side effects. This can lead to suboptimal treatment decisions and patient outcomes, which in turn drive higher incidences of repeat biopsy, delayed detection of significant disease, disease overtreatment, and serious complications. “Our goal is to enable physicians to provide patients with a safe, accurate and cost-effective method for MRI-guided prostate biopsies and interventions.”

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