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Insightec wins FDA nod for Exablate Neuro glioblastoma trial

November 28, 2017 By Fink Densford Leave a Comment

Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma. The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Neurological Tagged With: INSIGHTEC

FDA approves pivotal trial for Insightec’s Exablate Neuro in Parkinson’s

October 25, 2017 By Brad Perriello Leave a Comment

Insightec said today that it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease. Haifa, Israel-based Insightec said the the study will evaluate using Exablate Neuro’s MR-guided focused ultrasound to ablate portions of the globus pallidus in the brain, which helps regulate voluntary movement. The trial, led by […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Imaging, Radiosurgery/Radiation therapy Tagged With: INSIGHTEC

The 11 most innovative medical devices of 2017

October 19, 2017 By Danielle Kirsh Leave a Comment

The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]

Filed Under: Blood Management, Cardiac Implants, Cardiovascular, Catheters, Diagnostics, Hospital Care, Imaging, Implants, Mammography, Neurological, Patient Monitoring, Surgical, Wound Care Tagged With: Abbott, Allergan, Biosense Webster, Boston MedTech Advisors, Boston Scientific, BrainScope, depuysynthes, Ethicon, INSIGHTEC, Integra LifeSciences, Johnson and Johnson, Koning Corporation

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