The company is a member of the Bracco Group, a highly innovative health care group and world leader in global integrated solutions for the diagnostic imaging field. The Bracco Group is headquartered in Milan, Italy. Its North American operations consist of Bracco Diagnostics and Bracco Research USA, both located in Princeton, New Jersey. Bracco Diagnostics is one of the fastest growing developers and marketers of diagnostic pharmaceuticals in North America, with products for various imaging applications, including Isovue® (iopamidol) X-ray contrast agent, ProHance®, (gadoteridol), MRI contrast agent, and nuclear medicine products.
Gadoteridol has been available in Europe and the USA for several years. Holder of the Marketing Authorization: Bracco International B.V. - Strawinskylaan 3051 - 1077 ZX Amsterdam The Netherlands. (Contact: Kirk Deeter, Phone: +NL-303-838-8708)

The Bracco Group is the world's leading provider of global diagnostic imaging solutions, with net sales of more than 1 billion euro, of which more than 64% from international sales; it has operations in 115 countries and about 3,500 employees, of whom more than 600 work in R&D. Bracco invests around 15% of its turnover in R&D and has a portfolio of 1,500 patents worldwide. The Bracco Group deploys an integrated approach to diagnostic imaging, with an offer that encompasses contrast media, its core business where it is one of the world's top players, biomedical equipment from Esaote, one of the world's primary producers of magnetic resonance and ultrasonographic medical equipment, contrast media delivery systems from Acist Medical Systems, a top US company in advanced contrast media injection systems, and medical application software from EBIT-AET and Singapore's Volume Interactions, the leading developer of advanced medical software. Bracco has formed a high-level international research network, whose three centers in Milan, Geneva and Princeton study and develop products for the latest-generation diagnostic techniques, from X-rays and computerized axial tomography to magnetic resonance and echo contrast.

Ultrasound Contrast Agents:

(dB) A customary logarithmic measure most commonly used (in various ways) for measuring sound. Decibel is a way to express the ratio of two sound intensities: dB=10log10I1/I2 being I1 the reference. If one sound is 1 bel (10 decibel) 'louder' than another, this means the louder sound is 10 times louder than the fainter one. A difference of 20 decibel corresponds to an increase of 10 x 10 or 100 times in intensity.
The intensity of ultrasound decreases during the propagation and is measured in db/cm.
For sound pressure (the pressure exerted by the sound waves) 0 decibel equals 20 microPascal (μPa), and for ultrasonic power 0 decibel sometimes equals 1 picoWatt.

See also dB/dt, Phon, and Logarithms.

European Medicines Agency (EMA) is a decentralized body of the European Union with headquarters in Amsterdam.
'The EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. The EMEA has a role in both, but is primarily involved in the centralized procedure. Where the centralized procedure is used, companies submit one single marketing authorization application to the EMEA. A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant Committee concludes that quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the Commission to be transformed into a single market authorization valid for the whole of the European Union.'
'Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 25 EU Member States in a network of 42 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonization.'

See also Class I II III Devices, Phase 1 2 3 4 Drug Trials, and Drug Development and Approval Process USA.

The France-based Guerbet Group is highly specialized in contrast media for medical imaging. Its strategic goal is to be a key player in this market. Guerbet Group produces products for x-ray imaging, MRI, ultrasound imaging and imaging through radioactive tracers.

The earliest introduction of vascular ultrasound contrast agents (USCA) was by Gramiak and Shah in 1968, when they injected agitated saline into the ascending aorta and cardiac chambers during echocardiographic to opacify the left heart chamber. Strong echoes were produced within the heart, due to the acoustic mismatch between free air microbubbles in the saline and the surrounding blood.