NeuroLogica Corporation announced that ANVISA: National Health Surveillance Agency (charged with ensuring the safety of medical devices in Brazil) has granted marketing approval for its portable CT scanner, CereTom.
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 daily by leading hospitals and medical centers around the world.
We are extremely pleased with this new approval in Brazil. The CereTom will now be poised and ready to help save lives in this corner of the world. 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 the largest country in South America, Brazil.
Dr. Colin McDonald, Chief Medical Officer of Neurologica added, “Brazil has long been known as a Center of Neuro Excellence. We are happy to provide this dedicated group of Neurocritical Care professionals another useful tool in the battle against permanent brain injury.”
The Ceretom was required to pass rigorous safety testing by ANVISA prior to approval. In addition, NeuroLogica Corporation’s design and manufacturing systems previously demonstrated compliance with ISO 13485 International Quality System Requirements for Medical Devices and the US Food & Drug Administration Quality System Regulations.
CMS Medical, based in Brazil, is the local representative/distributor for the CereTom.