NeuroLogica Corporation Receives Chinese FDA & CQC Approval To Provide Its CereTom Portable CT Scanner Throughout China

Main Category: MRI / PET / Ultrasound
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 15 Jun 2009 - 2:00 PDT

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NeuroLogica Corporation, a provider of pioneering portable imaging equipment in CT and SPECT, announced its expansion into the Chinese medical device market with the approval of the company's life saving CereTom portable CT Scanner by the Chinese State Food and Drug Administration (FDA). The company also announced that it will establish a business liaison office in Beijing.

The CereTom is a portable eight slice CT scanner that can be used in the ICU, ER, OR, NICU, MICU, SICU, interventional suite, or any medical clinic. The CereTom is compact and lightweight; only 29 inches (74 cm) deep, five feet (153 cm) tall and four feet (134 cm) wide and weighs approximately 750 pounds (341kg). It is being used by leading hospitals and medical centers around the world.

"We are extremely pleased with the cooperative effort among various Chinese State agencies, and especially the FDA, in granting approval of our Portable CT scanner for the Chinese market," said Dr. Eric Bailey, President & CEO of NeuroLogica Corporation. "We believe the performance and convenience of our portable CT scanner will make a positive contribution to the quality of health care throughout China."

Final approval of the CereTom Portable CT to the Chinese standard included several key components. The device was required to pass safety testing by an independent Chinese testing laboratory, including review of submitted safety data regarding the scanner's history of performance. In addition, NeuroLogica Corporation's design and manufacturing systems had to demonstrate compliance with the rigorous ISO 13485 International Quality System Requirements for Medical Devices and the U.S. Food & Drug Administration Quality System Regulations. These reviews were completed by the Chinese government agencies with no reservations regarding the systems' capabilities.

Source
NeuroLogica Corporation