EOS imaging receives FDA clearance for Micro Dose
PARIS — EOS imaging (Paris:EOSI)(NYSE Euronext, FR0011191766 – EOSI), the pioneer in orthopedic 2D/3D imaging, announced today that the U.S. Food and Drug Administration has cleared the Micro Dose feature for pediatric imaging.
Micro Dose represents an important breakthrough for patients with orthopedic conditions requiring frequent imaging exams for the continuous monitoring of disease progression and treatment. Initial results presented at the 2013 French Society of Radiology Annual Meeting (JFR 2013) and during the 2014 Annual Meeting of the Radiological Society of North America (RSNA 2014)2,3concluded that Micro Dose generates dosage levels equivalent to a week of naturally-occurring background radiation in pediatric patients receiving 2D and 3D follow-up examinations.
EOS’ continued advancement of low dose radiation imaging addresses an important medical need for pediatric patients that remain particularly sensitive to adverse effects associated with excessive exposure to radiation. Most notably, pediatric patients with scoliosis require frequent imaging sessions to monitor treatment progression, which can increase the risk of radiation-induced cancer later in life4.
Marie Meynadier, CEO of EOS imaging, said, “The reduction of radiation exposure during orthopedic imaging exams remains a foremost concern among radiologists, orthopedic surgeons and patients. The Micro Dose solution is a giant step forward and is in full accordance with the ALARA (As Low As Reasonably Achievable) principle. We are pleased that the FDA’s clearance of our Micro Dose feature will now enable young patients to benefit from this technology in the United States.”
For further information about the Company or EOS®, the first full body, low dose 2D/3D imaging system, please visit http://www.eos-imaging.com/.
EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.
About EOS imaging:
EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system based on technology that enabled George Charpak to win the Nobel Prize for Physics, as well as associated solutions. The Company is authorized to market in 47 countries, including the United States (FDA), Japan and the European Union (EU). As of December 31, 2014 the Group posted 2014 consolidated revenue of €20.1 million and employed 107 people including an R&D team of 39 engineers. The Group is based in Paris and holds four subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada) and Frankfurt (Germany), and offices in Singapore.
1http://www.eos-imaging.com/uploads/PDFs/eos_imaging_micro_dose_101713.pdf
2radiologie ultra-basse dose pour le suivi des scolioses idiopathiques de l'adolescent. Alison et al – JFR 2013
3Reliability of sterEOS 3D Scoliosis Measurements Using a 5 Fold Reduction in Radiation. Newton et al – RSNA 2014
4Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Berrington de Gonzalez & Al, Lancet. 2012 Aug 4; 380(9840):499-505. Epub 2012 Jun 7.