Clear Guide Medical announced the FDA clearance for the Clear Guide Scenergy computer aided instrument guidance system, alongside the new TP Access Tool with SteriGRID.

Clear Guide Scenergy is a system that enhances image-guided diagnostic and interventional procedures. Leveraging image fusion, instrument recognition and tracking, multi-modal markers and target planning functionalities, the system provides clinicians with a solution for in-suite MR guided transperineal procedures.

“We are thrilled about the evolution of the Scenergy product. While we always believed it would have a profound impact on cancer screenings, the clinical results for transperineal interventions have been truly remarkable,” said Dr Nick Karahalios, Clear Guide Medical CMO.

For transperineal biopsy procedures, the Clear Guide Scenergy-TP allows clinicians to guide biopsy needles through the perineal skin into the prostate, minimizing the risk of contamination associated with transrectal biopsies.

According to the Mayo Clinic, this approach substantially eliminates the risk of sepsis compared to the risk associated with transrectal biopsy methods. The device further allows the diagnosis and treatment of metastatic lesions not available with transrectal procedures, which is reflected in the study featured on

The FDA clearance underscores the device’s compliance with regulatory standards, paving the way for its application in transperineal interventions, according to the company.

“This latest FDA clearance exemplifies our commitment to advancing medical technologies for the benefit of patients and healthcare professionals,” said Patrick Duke, Clear Guide Medical COO.