Page 24 - Device Designation News Today

Innovative multidisciplinary research at Washington University led to development of breakthrough device Eric Leuthardt, MD, professor of neurosurgery at Washington University School of Medicine, models a device that helps people disabled by stroke regain significant control over their arm and hand function by using their minds. Called the IpsiHand Upper Extremity Rehabilitation System, the first-of-its-kind device has received market authorization from the Food and Drug Administration. It was ...

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System April 26, 2021 07:00 ET | Source: Neurolutions Neurolutions IpsiHand also has been granted U.S. FDA Breakthrough Device Designation SANTA CRUZ, Calif. and ST. LOUIS, Mo., April 26, 2021 (GLOBE NEWSWIRE) -- Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-compu...

BrainQ hopes to uses AI-based electromagnetic therapy to reduce disability following a stroke (Courtesy) Israeli startup BrainQ said that a pilot trial of 25 stroke patients treated with its artificial intelligence (AI)-based electromagnetic therapy has shown “striking” results in reducing disability following a stroke. The Jerusalem-based startup has developed a wearable hat-like device that looks like a large round hair-dryer. This cloud-connected device aims to treat damaged areas of the...

Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System™ News provided by Share this article Share this article FREMONT, Calif. and OXFORD, United Kingdom, Feb. 11, 2021 /PRNewswire/ -- Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Des...