News

App to Diagnose Head Injuries Scores FDA 510(k) Clearance

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by Ramin A. Khalili, USAMRMC Combat Casualty Care Research Program Knowledge Manager

The new Defense Automated Neurobehavioral Assessment is a mobile phone-based application designed to help medical providers identify cases of traumatic brain injury in almost any setting, which may help clinicians diagnose a patient in as little as five minutes.

"This is what's important right now," said Lt. Col. Chessley Atchison, as he...

Stereotaxis Receives FDA 510(k) Clearance of Vdrive(R) With V-CAS(TM) System Along With Regulatory Approval of Odyssey(R) System in Japan

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by Globe Newswire

ST. LOUIS, Jan. 5, 2015 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (Nasdaq:STXS) announced today that it has received 510(k) clearance by the Food and Drug Administration (FDA) for its Vdrive® with V-CAS™ Catheter Advancement System in the U.S., representing the Company's third Vdrive system product to be cleared for market entry...

Phase One Medical Receives 510(k) Clearance for Symetrex™ Long Term Hemodialysis Catheter

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by PRWeb

Hingham, MA (PRWEB) December 09, 2014 -- Phase One Medical, LLC., a medical device company specializing in the development of venous access products, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Symetrex™ Long Term Hemodialysis Catheter indicated for hemodialysis and apheresis.

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Roxwood Medical Announces FDA 510(k) Clearance and US Commercial Launch of Its CenterCross Catheter

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by Business Wire

REDWOOD CITY, Calif.--()--Roxwood Medical Inc. announced today FDA 510(k) clearance for the US commercialization of its CenterCross Catheter for use in the coronary and peripheral vasculature. The CenterCross Catheter expands Roxwood Medical’s product offerings that already includes the FDA-cleared ...

Bio2 Technologies, Inc. Announces Receipt of FDA 510(k) Clearance for CLM Bioactive Scaffold

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by PRNewswire

WOBURN, Mass., Dec. 19, 2014 /PRNewswire/ -- Bio2 Technologies, Inc. (a privately held development stage company) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its CLM Bioactive Scaffold. ...

ReFlow Medical Corporation Announces FDA 510(k) Clearance And Initial US Clinical Use Of The speX™ Shapeable Support Catheter

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by Business Wire

SAN CLEMENTE, Calif.–(BUSINESS WIRE)—ReFlow Medical, Inc. (ReFlow) today announced FDA 510(k) clearance for US commercialization of their speX™ Shapeable Support Catheter for use in the peripheral vasculature as well as the first US clinical cases with the device. The initial US cases...

Stimwave Receives FDA Clearance for World’s First Injectable Wireless

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by Stimwave Technologies

Stimwave Technologies Incorporated, a medical device manufacturer and independent research institute headquartered in Miami Beach, Fla., has received FDA 510(k) clearance to market the world’s first wireless, micro-technology neuromodulation device for relief of chronic back and leg pain.  Currently being marketed throughout Europe, Stimwave’s revolutionary electroceutical device will be commercially available in the U.S...

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