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Nanobiodevice is a piece of contrivance,equipment,machine,or component,which is created by the overlapping multidisciplinary activities associated with nanotechnology and biotechnology,intended for biological,medical,and clinical purposes.During the past decade,nanobiodevice has progressively begun to focus on the establishment of main four fields of biomedical applications of nanotechnology,including 1) diagnostic devices,2) molecular imaging,3) regenerative medicine,and 4) drug delivery systems.In this lecture,I will describe the development of nanobiodevices to analyze biomolecules and cells towards biomedical applications(Fig.1).[1-10] I developed numerous diagnostic nanodevices based on the single biomolecular separation and detection.Euglena-based "biomimetic mechanical system" enables us to develop reliable CTC (circulating tumor cell) separation and detection technique for cancer metastasis diagnosis.Immunopillar devices realized the fast and low invasive "from blood to analysis" type biomarker detection of cancer with fM detection sensitivity within 2 min.Additionally,nanopillar devices give us ultrafast separation of DNA and microRNA within 100 μs and nanopillar-nanopore integrated nanobiodevice enables us ultarafast single molecular DNA sequencing (Fig.2).Quantum dots are applied to develop nanobiodevice for single cancer cell diagnosis,single molecular epigenetic analysis,in vivo imaging for stem cell therapy and theranostic device for cancer diagnosis/therapy.