Healthcare Industry News: neurodiagnostic
News Release - November 27, 2007
Natus Resumes Production and Shipping Operations at Olympic Facility
SAN CARLOS, Calif.--(HSMN NewsFeed)--Natus Medical Incorporated (Nasdaq:BABY ) today announced that it has resumed all production and shipping operations at its Olympic Medical manufacturing facility in Seattle, Washington.On October 15, 2007, Natus received a warning letter from the Food & Drug Administration ("FDA") related to the Olympic facility. The FDA letter focused on process deficiencies that were identified during an FDA inspection in April 2007. On November 1, 2007, the Company voluntarily shut down operations at the facility in order to adequately address the findings identified by the FDA. In a letter to the FDA dated November 27, 2007, Natus fully responded to the issues raised in the warning letter.
Jim Hawkins, President and Chief Executive Officer of Natus said, “After a complete review of all processes and procedures at our Olympic Medical facility, along with training of Olympic personnel, we feel confident that Olympic is in compliance with FDA requirements, and so we have now resumed production and shipments at the facility.”
In December 2006 Natus announced that it had received premarket approval ("PMA") from the FDA to market its Olympic Cool-Cap, a Class III medical device. The Cool-Cap system is the only FDA approved device for the treatment of hypoxic ischemic encephalopathy ("HIE") in term newborns, by providing selective head cooling to prevent or reduce the severity of neurologic injury associated with HIE.
Earlier this year, the Company announced that in transitioning production of the Olympic Cool-Cap from early clinical units to production units, some of the components used in the device were updated. Because the Cool-Cap is a FDA Class III medical device, those component updates require FDA pre-market clearance. In June 2007 the Company put a hold on shipments of Cool-Cap units while awaiting clearance from the FDA for the component updates. The company is still awaiting that clearance, and therefore it is not currently shipping Cool-Cap units in the United States.
About Natus Medical Incorporated
Natus is a leading provider of healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical ailments such as hearing impairment, neurological dysfunction, epilepsy, sleep disorders, and newborn care. Product offerings include computerized neurodiagnostic systems for audiology, neurology, polysomnography, and neonatology, as well as newborn care products such as hearing screening systems, phototherapy devices for the treatment of newborn jaundice, head-cooling products for the treatment of brain injury in newborns, and software systems for managing and tracking disorders and diseases for public health laboratories.
Additional information about Natus Medical can be found at www.natus.com.
Source: Natus Medical
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