Singapore, Jun 16, 2009: NeuroLogica, a provider of portable imaging equipment in CT and SPECT, announced its expansion into the Chinese medical device market with the approval of its life saving CereTom portable CT Scanner by the State Food and Drug Administration (SFDA) of China. The company also said that it will establish a business liaison office in Beijing, China.

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 equipment is compact and lightweight.

Commenting on the development, Dr Eric Bailey, President and CEO of NeuroLogica, said, “We are extremely pleased with the cooperative effort among various Chinese State agencies, and especially the SFDA, in granting approval of our Portable CT scanner for the Chinese market. 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 CereTom 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's design and manufacturing systems had to demonstrate compliance with the rigorous ISO 13485 International Quality System Requirements for Medical Devices and the US FDA Quality System Regulations. These reviews were completed by the Chinese government agencies with no reservations regarding the systems' capabilities.