News | Focused Ultrasound Therapy | October 01, 2018

FDA Approves Insightec's Exablate Neuro Compatibility With Siemens MRI Scanners

Expanded MRI compatibility increases potential patient access to focused ultrasound treatment for essential tremor

FDA Approves Insightec's Exablate Neuro Compatibility With Siemens MRI Scanners

October 1, 2018 — The U.S. Food and Drug Administration (FDA) approved the compatibility of Insightec’s Exablate Neuro focused ultrasound technology with Siemens Healthineers’ Magnetom Skyra, Prisma and Prisma[fit] magnetic resonance imaging (MRI) scanners to treat essential tremor (ET).

Exablate Neuro uses focused ultrasound to precisely target and accurately ablate tissue deep within the brain with no incisions. More than 1,500 medication-refractory essential tremor patients have been treated around the globe.

"Focused ultrasound is an exciting technology, through which radiology and neurosurgery expand efforts together to advance best patient care," said Satoshi Minoshima, M.D., Ph.D., professor and chair in the Department of Radiology and Imaging Sciences at the University of Utah Health, where the Exablate is currently being installed on a Magnetom Skyra from Siemens Healthineers. "The expansion of Exablate Neuro to be compatible with Siemens Healthineers MRIs will broaden access for patients to an incisionless treatment option."

Exablate Neuro is FDA-approved to treat medication-refractory essential tremor and clinical trials are ongoing to evaluate potential applications in the treatment of various neurological diseases.

For more information: www.insightec.com, www.usa.healthcare.siemens.com

Related Content

This illustration show the complexity of the data obtained from one single patient with moderate/severe traumatic brain injury. Different imaging approaches and techniques have their own unique sensitivity in assessing different aspects of neuroanatomy and neuropathology. What can be seen on images also changes with time since injury. Data from comprehensive clinical and functional assessments using a range of other tools is also important for evaluating patient outcome. Through data harmonization and large

This illustration show the complexity of the data obtained from one single patient with moderate/severe traumatic brain injury. Different imaging approaches and techniques have their own unique sensitivity in assessing different aspects of neuroanatomy and neuropathology. What can be seen on images also changes with time since injury. Data from comprehensive clinical and functional assessments using a range of other tools is also important for evaluating patient outcome. Through data harmonization and large-scale analyses of data combined across multiple research sites, the ENIGMA Brain Injury will develop and test methods and procedures for making sense of the complexity in this data. Images courtesy of Olsen et al., Brain Imaging and Behavior, 2020

News | Magnetic Resonance Imaging (MRI) | October 23, 2020
October 23, 2020 — Trau...
The fMRI hyperscanning environment.

(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).

News | Clinical Trials | October 22, 2020
October 22, 2020 — The potential impact of the patient-clinician relationship on a patient's response to treatment is
The FDA clearance, Quantib’s 6th to date, marks the first time a comprehensive AI prostate solution will be available to radiologists in the United States
News | Prostate Cancer | October 21, 2020
October 21, 2020 — Quantib, a market leader in...
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)

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)

News | Magnetic Resonance Imaging (MRI) | October 21, 2020
October 21, 2020 — According to an artic...
Flowchart of patient inclusion and exclusion.

Figure 1. Flowchart of patient inclusion and exclusion.

News | Coronavirus (COVID-19) | October 20, 2020
October 20, 2020 — A new multi-institutional study published in the journal ...
Ezra, a NY-based startup transforming early cancer screening using magnetic resonance imaging (MRI), announced that it has received FDA 510(k) premarket authorization for its Artificial Intelligence, designed to decrease the cost of MRI-based cancer screening, assisting radiologists in their analysis of prostate MRI scans. It is the first prostate AI to be cleared by the FDA.
News | Artificial Intelligence | October 20, 2020
October 20, 2020 — Ezra, a NY-based startup transforming early cancer screening using...
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)

56-Year-Old Woman With Benign Hemangioma: 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.

News | Magnetic Resonance Imaging (MRI) | October 16, 2020
October 16, 2020 —