PhotoniCare Inc., a medical device company headquartered in Champaign, Illinois, announces successful initiation of a multi-site registered clinical study to evaluate the imaging capabilities and image analysis performance of the PhotoniCare TOMi Scope.
Children’s National Health System (Washington, D.C.) is the first initiated of two clinical sites involved in this registered multi-site clinical study, along with Carle Foundation Hospital (Urbana, Illinois). The study is led by Dr. Diego Preciado, Children’s National, and Dr. Ryan Porter, Carle Hospital, along with a team of recognized otitis media experts at both clinical sites. This multi-center study plans to enroll a total of 300 pediatric subjects (up to 17 years old) undergoing tympanostomy tube surgery for chronic otitis media.
PhotoniCare’s TOMi Scope uses an advanced light-based technology to see through the eardrum. For the first time, physicians can view a high-resolution depth image on-screen to directly visualize the middle ear contents. Current diagnostic tools can only provide a view of the surface of the eardrum, while the disease resides in the middle ear, behind the eardrum. Physicians are left to make a diagnosis with very limited information, or employ invasive surgical procedures to diagnose middle ear pathologies. PhotoniCare’s noninvasive solution eliminates the guesswork, providing users with objective data upon which to base their decisions.