The Case Western Reserve University Department of Biomedical Engineering launched in 1968 as one of the first biomedical engineering programs in the world. Formally incorporated in both the School of Engineering and School of Medicine, the department provides full research and education programs and is consistently top-ranked for graduate and undergraduate studies, according to U.S. News & World Report.
 The program is headquartered in the Wickenden Building on the Case Western Reserve University campus in Cleveland, Ohio.
 The Department of Biomedical Engineering faculty and students collaborate on medical research with: Case Western Reserve University School of Medicine, University Hospitals Case Medical Center, Cleveland Clinic, Louis Stokes Cleveland VA Medical Center, and MetroHealth Medical Center
 The Case Institute of Technology launched the Engineering Design Center in 1960, from which the department would later emerge. 
 1972 – Case Western Reserve became one of the first schools to offer a bachelor's degree in biomedical engineering, with tracks in materials, instrumentation/electronics and systems/controls. The undergraduate program was one of the first accredited by the Engineers' Council for Professional Development (which later became the Accreditation Board for Engineering and Technology). 1977- The department's first hospital-based program, the Rehabilitation Engineering Center was created in relationship with MetroHealth Medical Center (then Cleveland Metropolitan General Hospital), the Cleveland VA Medical Center and the Department of Orthopaedics of the Case Western Reserve School of Medicine.
 The department had approximately 80 graduate students and 60 undergraduates. By the end of the decade, enrollment topped 100 graduate students and 120 undergraduates.  A Whitaker Foundation Special Opportunities grant and NSF grant supported a computer system for an image-computing laboratory.
 Throughout the 1990s, the department was consistently ranked among the top five in the nation by U.S. News & World Report. 1996 – The department received a multimillion-dollar Whitaker Development Award, which spurred a shift to biomedical engineering at the cellular and molecular levels. An NIH facilities grant allowed a space increase and renovation of the Wickenden building. 1997 – The student body exceeded 200 undergraduate students and 120 graduate students. 1999 – The Cleveland Functional Electrical Stimulation (FES) Center debuted.
 A continuation and extension of the Whitaker Development Award granted. The new BME Student Employment Program quadrupled co-op placements and doubled internship placements. 2002 – An $11.8 NIH award established the Center for Modeling Integrated Metabolic Systems. 2006 - Received a $4.5 million partnership award from the Wallace H. Coulter Foundation to for the Coulter-Case Translational Research Partnership (CCTRP) to support collaborative translational research projects among clinicians and biomedical engineering faculty to address unmet clinical needs and accelerate healthcare innovations from academia to market. The National Foundation for Cancer Research Center for Molecular Imaging at Case Western Reserve launched. 2008 – Received an anonymous $2 million gift to endow the CCTRP program directorship. 
 In 2012 the Center for Computational Imaging and Personalized Diagnostics opened, with Anant Madabhushi, PhD as the director. In 2018 the department of biomedical engineering at the Cleveland Clinic was formally recognized as a department in the Case Western Reserve University School of Medicine.