Clear Guide Medical

Clear Guide Medical is a medical device company, founded in 2010 as a spinout of Johns Hopkins University, that specializes in advanced image-guidance systems for minimally invasive procedures. The company was co-founded by Dorothee Heisenberg and Philipp Stolka. Heisenberg brought financial and strategic expertise from her time at JP Morgan Chase & Co., while Stolka provided the technical leadership from his background in surgical robotics and navigation systems.

The company develops and manufactures equipment for medical imaging fusion and navigation, designed to make interventions like biopsies, ablations, and nerve blocks more efficient and cost-effective. Its core technology is centered on a computer-aided instrument guidance system that enhances accuracy for needle-based procedures. The business model involves selling its hardware systems, which are designed as accessories compatible with most existing ultrasound machines, to hospitals and radiology practices. It also generates recurring revenue from the sale of disposables required for the procedures.

Clear Guide Medical's main product line is the CLEAR GUIDE SCENERGY, a system that fuses CT/MRI and ultrasound images in real-time. This allows clinicians to benefit from the clarity of a CT or MRI scan with the live visualization of an ultrasound, simplifying workflows and reducing procedure times. The system features automated registration, which significantly cuts down on the complex setup required by older fusion systems. The company has received multiple 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its products, including the initial CLEAR GUIDE ONE in 2014, the SCENERGY system in 2016, and an expanded clearance for transperineal interventions in 2024. This latest clearance enables procedures such as transperineal prostate biopsies, which reduce the risk of infection compared to transrectal methods.

Keywords: medical image guidance, ultrasound fusion, minimally invasive surgery, needle guidance, interventional radiology, computer-aided surgery, medical navigation, SCENERGY, transperineal biopsy, CT-ultrasound fusion, medical device, surgical navigation, image-guided interventions, instrument tracking, augmented reality surgery