News

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

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

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

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

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

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

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...

NEWS FLASH--QBTECH AB gains 510(k) clearance for QbCheck described as an Attention Task Performance Recorder

The U.S. Food and Drug Administration (FDA) announced today it has 510(k) cleared the QbCheck neurology product by QbTech AB.  QbCheck has a product classification code LQD which is described as an Attention Task Performance Recorder.

Save time with kBLASTER's unique result management features of sorting, My Favorites, Saved Search and Search History to quickly find your primary predicate, multiple predicates or reference devices to build a successful 510(k) clearance strategy. Save money by enabling...

FDA 510(k) Clearance Granted to PneumaCare's Ground-breaking Thora-3DI™ Product for Non-contact Respiratory Measurement

by PR Newswire

PneumaCare Ltd (Cambridge, UK) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Thora-3DI™ imaging device.

Thora-3DI™ is a non-invasive, non-contact device that uses a patented technology known as structured light Plethysmography (SLP) to measure breathing through detection of movement of the chest and abdomen. The technology can be used to accurately measure respiratory status in patients with a wide range of respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD),...

kBLASTER update March 2016: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from February 2016 and FDA 510(k) splash pages for 510(k)s clearances in March 2016. If you have Saved Searches in your kBLASTER account that meet the parameters of today...

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