European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in London.
'The EMA began its activities in 1995, when the European system for authorising medicinal products was introduced, providing for a centralised and a mutual recognition procedure. The EMA has a role in both, but is primarily involved in the centralised procedure. Where the centralised procedure is used, companies submit one single marketing authorisation application to the EMA. 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 authorisation 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 EMA coordinates the evaluation and supervision of medicinal products throughout the European Union. The Agency brings together the scientific resources of the 28 EU Member States in a network of over 40 national competent authorities. It cooperates closely with international partners, reinforcing the EU contribution to global harmonisation.'

The company is a leading manufacturer and developer of magnetic resonance imaging (MRI) scanners. The Patient Friendly MRI Company, formed in 1978, is engaged in the business of inventing, manufacturing, selling and servicing magnetic resonance imaging (MRI) scanners. FONAR is the oldest MRI company in the world. After receiving hundreds of millions in a windfall from protecting their MRI patents, they made a MRI scanner that no other MRI manufacturer has. One that the patient stands in and they call Indomitable, the Stand-Up MRI. Patients like it because it is the least claustrophobic, most comfortable MRI on the market. Doctors like it because of its superior image quality and for the first time, the patient can be scanned in the weight-bearing position, or the position of pain or symptom. In October of 2004, the company changed the product name of the Stand-Up MRI to the Upright MRI. Fonar introduced the first "open" MRI scanner in 1980 and is the originator of the iron-core nonsuperconductive and permanent magnet technology.

MRI Scanners:

- 0.6T:

(FDA) An agency of the US federal government established by Congress in 1912 and presently part of the US Department of Health and Human Services. The FDA gives classifications of medical devices according to potential risks and controls the safety of marketed drugs.

See also Class I II III Devices, Phase 1 2 3 4 Drug Trials and Legal Requirements.

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. Products include Dotarem (Magnetic Resonance Imaging) and Xenetix (X-ray Imaging).

MRI Contrast Agents:

Hologic's main businesses are osteoporosis assessment, mammography and breast biopsy. In September 2005 Hologic Inc. entered an exclusive distribution and service agreement for extremity MRI imaging systems manufactured by Esaote SpA (initial term of three years, with automatic 1-year renewal options). Under this agreement Hologic, Inc. distributes the C-Scan™, the Opera E-SCAN™ XQ and the S-Scan in the USA.