A Diagnostics & Imaging Week
NeuroLogica (Danvers, Massachusetts), a provider of portable imaging equipment in CT and SPECT, has expanded into the Chinese medical device market with the approval of the company's life CereTom portable CT Scanner by the Chinese State Food and Drug Administration.
The company also said 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 unit is compact and lightweight; only 29 inches deep, 5 feet tall and 4 feet wide and weighs roughly 750 pounds.
"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 President/CEO Dr. Eric Bailey. "We believe the performance and convenience of our portable CT scanner will make a positive contribution to the quality of healthcare 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's design and manufacturing systems had to demonstrate compliance with the rigorous ISO 13485 international quality system requirements for medical devices and the FDA's Quality System Regulations.
NeuroLogica's products are CE-marked for distribution in Europe.
New software from TomTec
TomTec (Munich, Germany) has launched its 2-D Cardiac Performance Analysis software as part of its CardioArena multimodality imaging solution at the American Society of Echocardiography congress in Washington.
2-D Cardiac Performance Analysis allows cardiologists to study the behavior of the heart muscle quickly and easily. Quantitative assessment of displacement, velocity and strain in individual muscle segments is available. The diagnosis of pathologies like hypertrophic cardiomyopathy or dyssynchronous ventricles improves with this software and the decision for a cardiac resynchronization therapy is then more confident.
2-D Cardiac Performance Analysis is a speckle tracking based analysis tool which can analyze 2-D data from various ultrasound machines. The user can utilize the data of different ultrasound systems and is not limited to specific vendors.
Already-acquired studies can also be analyzed with TomTec's 2-D Cardiac Performance Analysis.
New chairman for DxS
DxS Ltd. (Manchester, UK), a personalized medicine company and developer of companion diagnostics, reported the appointment of Ron Long as chairman.
Long has 40 years' experience in both public and private companies, including leadership of the Wellcome Foundation and Amersham, where he was vice chairman.
He has served as non-executive director of DxS since July 2008 and replaces David Evans as chairman, who steps down. Long retains his positions at Medivir AB and Procognia Israel Ltd.
DxS has more than doubled in size in the last 12 months, with new manufacturing space taken at its Manchester site as a result of a global distribution deal agreed with Roche Molecular Diagnostics for its TheraScreen diagnostic kits, and a deal which has seen Amgen and Merck Serono/Bristol Myers Squibb use DxS' TheraScreen: K-RAS Mutation Kit as a companion diagnostic for the colorectal cancer treatment Vectibix and Erbitux.
Cystic fibrosis tests launched
Luminex (Austin, Texas) reported launching two new cystic fibrosis (CF) tests in Europe, the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2, as CE-marked IVD products under the European Directive on In Vitro Diagnostic Medical Devices.
The new xTAG tests will be used to provide assistance in CF screening for newborns and confirmatory diagnostic testing in newborns and children. The tests also can be used for carrier testing in adults of reproductive age.
Cystic fibrosis can only be inherited when both of a child's parents carry a CFTR gene mutation that causes the disease. About 36,000 Europeans have cystic fibrosis. Each year 2,500 children with the disease are born. According to the European Cystic Fibrosis Society, as many as one in 30 Europeans are carriers of a CF-causing gene mutation.
"The geographic distribution of CFTR gene mutations differs significantly among the European populations," said Milan Macek, professor of medical and molecular genetics in the Division of Clinical Molecular Genetics and the National Cystic Fibrosis Center at University Hospital Motol and 2nd School of Medicine Charles University (Prague, Czech Rebublic). "The possibility of having a test that can cover a wide range of mutations found in different ethnic groups is very important and will allow doctors to have better confidence around CF diagnosis, especially when we have cases where the ethnicity of the patient is difficult to assess."
Lumenix said the xTAG Cystic Fibrosis 39 Kit v2 "can quickly and accurately detect up to 39 of the most common CFTR gene mutations from a child or parent's blood sample or bloodspot in a matter of hours. The xTAG Cystic Fibrosis 71 Kit v2 can screen for all of the genetic mutations in the xTAG Cystic Fibrosis 39 Kit v2 plus an additional 32 mutations including those that are typically found in specific ethnic populations."
The xTAG tests also are designed to be fast and easy for use, requiring only about one hour of hands-on time to process 48 purified samples. They offer physicians the ability to select the CFTR gene mutations for which they want to test.
MDS producing PET agent for Bracco
MDS Nordion (Ottawa, Ontario), a major provider of medical isotopes and radiopharmaceuticals, said that it has begun the manufacture of CardioGen-82 (Rubidium-82 generators), for Bracco Diagnostics (Princeton, New Jersey), part of Bracco Group, one of the world's leading companies in the production of imaging agents.
MDS Nordion said it has designed and built a dedicated manufacturing suite within its FDA-approved, Good Manufacturing Practices-compliant production facility in Ottawa.
CardioGen-82, the only generator-based, cardiac PET perfusion imaging agent approved by the FDA, produces Rubidium-82 using a specialized generator technology. Once administered to the patient, Rubidium-82 is used as a PET imaging tracer for perfusion studies of the heart to examine blood flow through heart vessels.
PET is a medical imaging technique that produces a 3-D image of the functioning heart, allowing the cardiologist to identify regions of the heart muscle receiving poor blood flow.
"This is an important milestone in the development of Bracco's . . . cardiac imaging technology, and the new MDS facility provides Bracco with a world-class manufacturing capability with significant capacity for future expansion to meet anticipated market growth," said Carlo Medici, president/CEO of Bracco Diagnostics. "MDS Nordion's unique expertise in the development and manufacture of radiopharmaceuticals, along with its highly specialized facilities, made them an obvious choice when Bracco looked to expand its CardioGen-82 production capacity."