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Ultrasound Homepage

German Armed Forces purchases 142 Philips Lumify app-based ultrasound systems Will be standard equipment in emergency and rescue operations

Focused Ultrasound Foundation receives $10 million donation from anonymous donor 'Huge, transformative' for the field of focused ultrasound

Study finds focused ultrasound can reduce Parkinson's tremor Research underway to find additional applications

$10 Nintendo chip turns ultrasound machine into 3-D scanner A potential game-changer for obtaining quick scans in the trauma unit

FDA approves ultrasound that connects to iPhone and will be sold for less than $2000 The world's first 'ultrasound-on-a-chip'-based imaging system

Clinical trial combining focused ultrasound and immunotherapy underway Aim is to enhance the ability of the immune system to recognize tumors

Henry Schein to distribute Terason’s uSmart 3200T NexGen portable ultrasound Enabling point-of-care exams during transportation in emergency vehicles

Esaote launches MyLab9 eXP ultrasound system Designed to enhance image clarity, workflow and performance

Bracco Imaging acquires SurgVision Enables development of a real-time fluorescence image-guided surgery platform

Soccer club PSV Eindhoven utilizes Philips Lumify portable ultrasound Assesses injuries of players immediately at the point of care

The FDA has approved a pivotal study
involving Exablate Neuro in the treatment
of Parkinson's disease

FDA approves study with INSIGHTEC’s Exablate Neuro for Parkinson’s

by John Fischer , Staff Reporter
The FDA has approved a pivotal study involving the use of INSIGHTEC’s Exablate Neuro system for treating advanced Parkinson’s disease patients who have not responded to medication.

The study aims to test the efficiency of the MR-guided focused ultrasound device in reducing dyskinesia symptoms, characterized by uncontrolled, involuntary movement of the arms and legs, and improving motor function in patients.

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“The goal is [that] if the study turns out favorably, then the FDA would consider it favorably if it could,” Howard Eisenberg, the chair of the department of neurosurgery at the University of Maryland School of Medicine and the principal investigator for the study, told HCB News. “It helps by having the FDA approve the protocol before the study starts, so their anticipated questions can be resolved before you commit a bunch of patients to a study.”

Exablate Neuro uses focused ultrasound to target and ablate tissue deep in the brain without the need for surgical incisions.

The trial will consist of 115 patients, with entry criteria based on the presence of dyskinesia symptoms and differences observed in patients between on and off periods during their time on medication.

"INSIGHTEC remains committed to advancing research to expand indications for our incisionless focused ultrasound technology to improve patient lives," Maurice R. Ferré M.D., chief executive officer and chairman of the board at INSIGHTEC, said in a statement.

The FDA approved Exablate Neuro in July 2016 as the first focused ultrasound device in the treatment of medication-refractory essential tremor.

The study is projected to begin at some point in 2018.

INSIGHTEC did not respond for comment.

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