News

NEWS FLASH--TRISTAN TECHNOLOGIES Gains 510(k) Clearance for MagView BIOMAGNETOMETER SYSTEM as a Magnetoencephalograph

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The U.S. Food and Drug Administration (FDA) announced this week it has 510(k) cleared the MagView BIOMAGNETOMETER SYSTEM neurology product by TRISTAN TECHNOLOGIES. MagView BIOMAGNETOMETER SYSTEM has a product classification code OLY which is described as a Magnetoencephalograph.

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DICOM Grid Announces FDA 510(k) Clearance Of Next Generation Cloud PACS And Zero-Footprint Diagnostic Viewer

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New York, NY – April 5, 2016 – DICOM Grid, makers of the leading cloud-based, medical image management suite, today announced FDA 510(k) clearance and new features for managing, viewing, and interpreting medical images with next generation cloud PACS and HTML 5, zero-footprint diagnostic viewer tools. To leverage these and other industry-leading...

Ekso GT Robotic Exoskeleton 510(k) Cleared for Stroke Rehab, Spinal Cord Injuries

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by MedGadget

Ekso Bionics (NASDAQ: EKSO) won FDA 510(k) clearance to offer its Ekso GT powered exoskeleton for rehabilitation of patients who suffer from partial paralysis caused by a stroke and for those with spinal cord injuries between levels T4 and L5 and T3 to C7. The device can provide varying amounts of assistance to one or both legs depending on the patient’s needs and what the rehab specialist is recommending.

As the patient makes steps, a rehabilitation...

Great Basin Receives FDA 510(k) Clearance for First Multiplex Panel

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Salt Lake City—Great Basin Scientific, Inc., (NASDAQ: GBSN) a molecular diagnostics company, has received U.S. Food & Drug Administration (FDA) 510(k) clearance for its Staph ID/R Blood Culture Panel, following submission in August 2015. The Company received notification of clearance from the FDA on March 25, 2016. This is Great Basin’s first multiplex panel to receive FDA clearance, adding to the value and versatility of the company’s analyzer, which is capable of performing...

FDA 510(k) Clears Parker’s Indego® Exoskeleton for Clinical, Personal Use; State-of-the-Art Device Allows Individuals with Spinal Cord Injury to Stand and Walk

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CLEVELAND (GLOBE NEWSWIRE) -- Parker Hannifin Corporation (NYSE: PH), the global leader in motion and control technologies, announced in March 2016 that the U.S. Food and Drug Administration (FDA) has given clearance to market and sell the ...

Xtant Medical Announces FDA 510(k) Clearance of the Xspan™ Laminoplasty Fixation System

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by Globe Newswire

BELGRADE, Mont., (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, announced that its wholly owned subsidiary, X-spine Systems, received FDA clearance of the Xspan™ Laminoplasty Fixation System.

The Xspan™ System represents the latest generation of laminoplasty fixation. Spinal laminoplasty is a surgical procedure performed to remove pressure from the...

Tenex Health Secures FDA 510(k) Clearance for the TX2 MicroTip, Providing a Minimally Invasive Solution for Chronic Tendinosis

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by PR Newswire

LAKE FOREST, Calif., March 29, 2016 -- Tenex Health Inc. has obtained FDA 510(k) clearance for its new TX2 MicroTip. The TX2 MicroTip will primarily be utilized to address tendinosis of the shoulder and hip, two areas that were more difficult to reach using the original TX1 MicroTip due to its length.

Tendinosis of the shoulder and hip affects approximately 5 million persons in the US alone every year. The company plans to make the TX2...

FDA 510(k) Clears CorPath Robotic System for Use in Peripheral Vascular Intervention

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WALTHAM, MA - March 29, 2016 – Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS], a leading developer of precision vascular robotics, announced today that the U.S. Food and Drug Administration has 510(k) cleared the CorPath® System for use in peripheral vascular interventions. This is the third clearance for the CorPath System including the initial clearance for percutaneous coronary intervention...

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