Medical Device Division — Medical Device Imaging Core Lab

Intrinsic Imaging's Medical Device Division provides specialized medical imaging core lab services for the clinical evaluation of Class I, II, and III medical devices across a broad range of therapeutic applications and regulatory pathways. Our board-certified, fellowship-trained radiologists combine subspecialty clinical expertise with extensive experience in the imaging-based assessment of medical devices, including implanted devices, stents, catheters, embolization and stroke devices, drug and biologic delivery systems, biopsy equipment, diagnostic software, artificial intelligence and computer-aided detection technologies, and other novel devices. From early feasibility and proof-of-concept studies through pivotal clinical investigations supporting 510(k) submissions and Premarket Approval (PMA) applications, Intrinsic Imaging works with medical device manufacturers to develop scientifically rigorous imaging strategies capable of objectively evaluating device placement, technical performance, safety, durability, and clinical effectiveness.

Intrinsic Imaging provides comprehensive support throughout the medical device clinical trial lifecycle, including protocol development, imaging endpoint strategy, imaging charter development, modality selection, site and equipment qualification, standardized image acquisition, image quality control, reader training and qualification, centralized independent review, adjudication, quantitative analysis, and regulatory-ready data delivery. Our imaging expertise encompasses CT, advanced three-dimensional imaging and reconstruction techniques, radiography, ultrasound, DXA, nuclear medicine, and PET, with study-specific methodologies developed according to the device, anatomy, mechanism of action, and intended clinical endpoint. As an ISO 13485-certified imaging core lab, Intrinsic Imaging applies a disciplined quality framework to medical device clinical investigations, with particular emphasis on traceability, reproducibility, standardized assessment, and the reduction of site and reader variability. By integrating regulatory experience, subspecialty physician expertise, sophisticated imaging methodologies, and rigorous quality systems, Intrinsic Imaging provides medical device sponsors with the scientific and operational infrastructure required to generate robust, objective imaging evidence throughout the device development and regulatory approval process.