FDA Clears Pediatric-Specific Technology from EOS Imaging

EOS Imaging, which specializes in 2-D and 2-D orthopedic imaging systems, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Micro Dose feature for pediatric imaging. The application process began in September last year, company officials confirmed to Orthopedic Design & Technology.

According to the company, 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 and during the 2014 Annual Meeting of the Radiological Society of North America, concluded that Micro Dose generates dosage levels equivalent to a week of naturally occurring background radiation in pediatric patients receiving 2-D and 3-D follow-up examinations.

The company’s 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 life.

“The reduction of radiation exposure during orthopedic imaging exams remains a foremost concern among radiologists, orthopedic surgeons and patients,” said Marie Meynadier, CEO of EOS imaging. “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.”

As far as commercialization plans for Micro Dose, EOS plans to upgrade all existing installations located in pediatric facilities, and offer the option to future pediatric prospects, according to EOS officials.

And there’s a significant market share to tap. According to figures cited by EOS, there are about 250 children’s hospitals in the United States and about 100-125 of them provide a “robust orthopedic program,” officials told ODT.

EOS is authorized to market in 47 countries. As of Dec. 31, 2014, the Group posted 2014 consolidated revenue of 20.1 million euros and employed 107 people. In addition to its base in Paris, the company has facilities in Besançon, France; Cambridge, Mass.; Montreal, Canada; Frankfurt, Germany; and Singapore.