EDAP Announces FDA Clearance for Focal One HIFU Prostate Ablation System

(A) The fMRI hyperscanning environment. The clinician (1) and patient (2) were positioned in two different 3T MRI scanners. An audio-video link enabled online communication between the two scanners (3), and video images were used to extract frame-by-frame facial expression metrics. During simultaneous acquisition of blood oxygen level–dependent (BOLD)–fMRI data, the clinician used a button box (4) to apply electroacupuncture (EA) treatment (real/sham, double-blind) to the patient (5) to alleviate evoked pressure pain to the leg (6; Hokanson cuff inflation). Pain and affect related to the treatment were rated after each trial. (B) Study overview. After an initial behavioral visit, each individual participated in a Clinical-Interaction (hyperscan preceded by a clinical intake) and No-Interaction condition (hyperscan without a preceding intake), in a counterbalanced order, with two different partners. (C) Experimental protocol. Each hyperscan was composed of 12 repeated trials (four verum EA, four sham EA, and four no treatment) in a pseudo-randomized order. After a resting period (far left), both participants were shown a visual cue to indicate whether the next pain stimulus would be treated (green frame) or not treated (red frame) by the clinician. These cues prompted clinicians prepare to either apply or not apply treatment while evoking corresponding anticipation for the patient. Following the anticipation cue, moderately painful pressure pain was applied to the patient’s left leg, while the clinician applied or did not apply treatment, respectively. After another resting period, participants rated pain (patients), vicarious pain (clinicians), and affect (both) using a visual analog scale (VAS).

Lesion was originally reported as indeterminate enhancing mass, and outside report recommended biopsy. Classic features of benign hemangioma are shown. Error was attributed to faulty reasoning. A, Axial MR image obtained 5 minutes after contrast agent administration shows peripheral nodular discontinuous enhancement. B, Axial MR image obtained 10 minutes after contrast agent administration shows centripetal progression of enhancement (arrow). C, Axial fast imaging employing steady-state acquisition (FIESTA) MR image shows lesion is homogeneously hyperintense compared with liver parenchyma. Image courtesy of American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)