Heart Test Laboratories Inc., of Westlake Texas, has achieved ISO 13485:2003/NS-EN ISO 13485:2012 certification for its quality management systems. The certification includes activities related to the design and development, manufacturing, distribution and servicing of active non-invasive electrocardiographic devices for screening for a variety of cardiac abnormalities and disease.
Impedimed Ltd. , of Carlsbad, Calif. opened a regional office in Bloomington, Minn. and added Ann Holder and Jack Cosentino to its executive leadership team. These moves cap an eventful several months for the 55-person company, which develops products using bioimpedance spectroscopy to measure, monitor and manage fluid status and body composition.
Magnetic Insight Inc. signed a supply agreement with Tokyo-based Meito Sangyo Ltd., a provider of chemicals and enzymes in a variety of industries, including diagnostics. Magnetic, of Alameda, Calif., agreed to develop and market Vivotrax, a superparamagnetic iron oxide nanoparticle coated with carboxydextran, as a tracer to support stem cell and immune cell tracking in research for both magnetic particle imaging (MPI) and MRI applications. The Vivotrax cell tracking kit uses Meito's Ferucarbotran product, a well-established precursor iron oxide material with translational uses in the clinic. According to Magnetic, MPI is a new imaging technology emerging into the market this year with a key application in the non-invasive imaging of cells with unparalleled contrast, without radiation and depth limitations. The technology harnesses the magnetic properties of specific types of iron oxide nanoparticles, the company said. Meito's iron oxide nanoparticle technology is used as a MPI tracer.
Medical Alarm Concepts Holding Inc., of King of Prussia, Pa., changed its name to Wearable Health Solutions Inc. The company is now trading under a new ticker symbol (OTCQB: WHSI).
Russia's first dedicated proton therapy treatment center installed a cyclotron from equipment supplier Varian Medical Systems Inc., of Palo Alto, Calif. Because the installation of the particle accelerator required cranes to lift it, the event was monitored by local government officials of Petersburg, Russia. The cyclotron is a core piece of equipment of Varian's Probeam system, which is equipping the two-room PTC St. Petersburg Center of Nuclear Medicine of the International Institute of Biological Systems. Clinicians there expect to treat about 1,000 patients year, beginning late next year.