m2m Imaging relocating to Cleveland

m2m Imaging reported that it has relocated its headquarters from New Jersey to Cleveland.

m2m is the combination of spin-out businesses from Columbia University and the University of Queensland (Brisbane, Australia). It said the Cleveland HQ includes advanced R&D, sales and marketing; additional R&D and ISO 9001/13485-certified manufacturing are located in Brisbane. m2m says its customers include a majority of U.S. and EU academic teaching institutions, pharmas and global medical imaging system manufacturers.

"We are pleased to be joining NE Ohio's regional medical imaging technology cluster, including Case Western Reserve University's Center for Imaging Research and Biomedical Engineering, the Cleveland Clinic, and a host of world-class companies, both large and small, who call Northeast Ohio their home" said C. Richard Hullihen, CEO of m2m Imaging. "We've been in discussion with BioEnterpise and other several other regional development groups over the past two years and chose Cleveland because the area offers a rich history and unique combination of scientific collaboration, professional talent and supply chain infrastructure."

m2m imaging makes solutions for high-definition preclinical and clinical MRI coils and accessories.

2 states add cystic fibrosis screens

Illinois and Vermont have joined 37 other states and the District of Columbia in requiring that all newborns be screened for cystic fibrosis at birth, according to the Cystic Fibrosis Foundation (Washington). In addition, the Nevada Department of Health has decided to begin regular CF screening as well. Routine screening will be implemented when state lawmakers set an implementation date.

"Early diagnosis for cystic fibrosis is critically important because it gives every newborn a better chance for better health and a longer life," said Robert Beall, PhD, president/CEO of the Cystic Fibrosis Foundation. "We congratulate the 40 states in the country who are now screening for the disease, and look forward to every state in the union joining this important effort."

Power3 Medical receives CLIA recertification

Power3 Medical Products (Houston), a company specializing in diagnostic tests for the early detection of breast cancer and neurodegenerative diseases, has received its CLIA compliance recertification following a CLIA regulatory inspection.

Power3 earned its CLIA recertification to offer high complexity tests after meeting standards for knowledge, training, expertise, quality control, quality assurance, and testing proficiency. With CLIA recertification, Power3 is able to continue offering its blood serum-based tests, BC-SeraPro and NuroPro.

CLIA, or Clinical Laboratory Improvement Amendments, are U.S. federal regulatory standards that apply to all clinical laboratory testing performed on humans in the U.S., except clinical trials and basic research. The CLIA Program sets standards and issues certificates for clinical laboratory testing. The FDA has assumed primary responsibility for performing the complexity categorization functions that include the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential risk to public health.