OCTOBER 23, 2008 -- InfraScan (Philadelphia, PA), a medical device firm specializing in brain injury diagnostic products, says it has obtained the CE mark, European marketing clearance, for its Infrascanner handheld intracranial hematoma detector. InfraScan plans to launch international sales this fall.
The Infrascanner is a small, completely portable device, that can detect the presence and location of a brain hematoma based on differential near infrared (NIR) light absorption of a hematoma and normal brain tissue. InfraScan will present the results of a pivotal (400 patient) multicenter study to the FDA later this year to support its 510k application and a subsequent U.S. launch of the device. A pilot study with an earlier Infrascanner prototype involving more than 300 patients demonstrated high sensitivity for detecting bleeding in the brain and for rapidly detecting the onset of delayed hematomas.
The company says that Infrascanner is the first handheld device of its kind designed to assist first responders and emergency room personnel in identifying life threatening brain hematomas, allowing expedient assessment of patients and potentially facilitating crucial treatment. Intracranial hematomas resulting from a traumatic brain injury are life-threatening and patient outcomes can improve significantly if treated within an hour after an injury. While most hospitals have a Computer Aided Tomography (CAT) scanner, which is viewed as the state-of-the-art technology for diagnosing a brain hematoma, many facilities lack the neurosurgical capabilities to treat the condition. The early identification of a brain hematoma can play a significant role in facilitating transportation of critically injured patients to facilities, which can both verify Infrascanner's early diagnosis and offer surgical intervention.
"Receiving our CE mark represents significant progress toward InfraScan's strategic goal of providing our potentially life saving technology to patients in some of the world's top established and emerging markets," said Baruch Ben Dor, PhD, president and CEO of InfraScan. "Earlier this year, InfraScan passed a British Standards Institute audit and received ISO 13485:2003 quality certification. This facilitated our obtaining the CE Mark for the Infrascanner and allowed us to sign our first distributors in the UK, Spain, Israel, India and Africa." The CE Mark certifies that Infrascanner has met European Union (EU) health, safety and environmental requirements.
In addition to the Infrascanner's first application for detecting brain hematomas, the company will pursue future applications for the product, including the monitoring of stroke victims using the same NIR technology.