{"entity":{"id":"prostate-fusion-biopsy-systems","kind":"technology","name":"MRI-ultrasound fusion prostate biopsy systems (UroNav, Artemis, KOELIS Trinity, Mona Lisa)","aka":["Fusion biopsy","MRI fusion biopsy","MRI-targeted prostate biopsy","UroNav","Artemis","KOELIS Trinity","Fusion Bx","iSR'obot Mona Lisa","BiopSee","bkFusion","FusionVu","Biojet"],"tldr":"Software that lays the prostate MRI over the live ultrasound picture during a biopsy, so the needle can be aimed at the area the MRI flagged. NICE found too little evidence to recommend it for routine use over the doctor fusing the images by eye.","summary":"NICE HealthTech guidance HTG678 (formerly DG53, published 24 May 2023) assessed nine systems (Artemis, Biojet, BiopSee, bkFusion, Fusion Bx, FusionVu, iSR'obot Mona Lisa, KOELIS Trinity and UroNav) and concluded: \"There is not enough evidence to recommend routine adoption of MRI fusion biopsy systems for diagnosing prostate cancer.\" Centres already using them may continue but are encouraged to collect data comparing them with cognitive fusion, in which the operator targets the MRI lesion by eye on ultrasound. In the United States they are cleared as image-processing or ultrasound systems: UroNav 3.0 (Invivo, K182561, 19 October 2018) and UroNav 4 (Philips, K250800, 5 June 2025), Eigen's Artemis (K222222, 12 October 2023), KOELIS Trinity (K160357, 2 May 2016; K170521, 30 May 2017), Focal Healthcare's Fusion Bx 2.0 (K181290, 15 June 2018) and Biobot's iSR'obot Mona Lisa 2.0 (K213411, 22 December 2021; K232320), a robotic needle guide that its summary describes as fusing ultrasound and MRI for diagnostic and interventional procedures on the prostate.","status":"established","asOf":"2026-11-04","links":[{"label":"NICE HTG678: MRI fusion biopsy systems for diagnosing prostate cancer","url":"https://www.nice.org.uk/guidance/htg678"},{"label":"FDA 510(k) K182561: UroNav 3.0 (19 October 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182561"},{"label":"FDA 510(k) K250800: UroNav 4 (5 June 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250800"},{"label":"FDA 510(k) K222222: Eigen Artemis (12 October 2023)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222222"},{"label":"FDA 510(k) K160357: KOELIS Trinity (2 May 2016)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K160357"},{"label":"FDA 510(k) K181290: Fusion Bx 2.0 (15 June 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181290"},{"label":"FDA 510(k) K213411: iSR'obot Mona Lisa 2.0 (22 December 2021)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213411"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["prostate"],"sections":["diagnostics","imaging","devices"],"technologies":["mp-mri","transperineal-prostate-biopsy-devices","ultrasound","image-guided-percutaneous-robots"],"targets":[],"drugs":[],"companies":["philips"],"institutions":[],"pathways":[],"terms":["pi-rads","template-mapping-biopsy","biopsy"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"The MRI volume with the radiologist's contoured lesion is registered rigidly or elastically to a three-dimensional ultrasound sweep of the prostate, and the fused target is shown on live ultrasound to guide transrectal or transperineal needles.","strengths":["Targets MRI-visible lesions on a live display","Records where each core was taken"],"limitations":["NICE found not enough evidence for routine adoption over cognitive fusion","Equipment and set-up cost"],"since":2016},"route":"/technologies/prostate-fusion-biopsy-systems/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"imaging","kind":"section","name":"Imaging","route":"/fronts/imaging/"}],"technology":[{"id":"image-guided-percutaneous-robots","kind":"technology","name":"CT-guided needle robots and percutaneous navigation (XACT ACE, Epione, MICROMATE, CAS-One IR)","route":"/technologies/image-guided-percutaneous-robots/"},{"id":"transperineal-prostate-biopsy-devices","kind":"technology","name":"Freehand transperineal prostate biopsy devices (PrecisionPoint and others)","route":"/technologies/transperineal-prostate-biopsy-devices/"},{"id":"mp-mri","kind":"technology","name":"Multiparametric prostate MRI (PI-RADS)","route":"/technologies/mp-mri/"},{"id":"ultrasound","kind":"technology","name":"Ultrasound","route":"/technologies/ultrasound/"}],"company":[{"id":"philips","kind":"company","name":"Philips","route":"/companies/philips/"}],"term":[{"id":"biopsy","kind":"term","name":"Biopsy","route":"/terms/biopsy/"},{"id":"pi-rads","kind":"term","name":"PI-RADS (Prostate Imaging Reporting and Data System)","route":"/terms/pi-rads/"},{"id":"template-mapping-biopsy","kind":"term","name":"Template mapping biopsy (transperineal template prostate mapping)","route":"/terms/template-mapping-biopsy/"}]}}