Ear infections are a common occurrence in kids, causing pain, fever and, in worst cases, hearing loss. Yet up to half of all cases are misdiagnosed, due to doctors’ inability to look deep into the middle ear where infections reside. Now, the U.S. FDA has cleared the Tomi Scope, a first-in-class technology from Photonicare Inc., of Champaign, Ill., that allows doctors to not only detect the presence or absence of fluid in the middle ear but characterize the type of fluid they see.
The screening of at-risk patients for Barrett’s esophagus, a precursor to esophageal cancer, has long been a goal for health systems. Currently, most patients with the condition remain undiagnosed, and more than 90% of individuals are identified after it has progressed into esophageal cancer via endoscopy, according to a 2018 paper in Digestive Diseases and Sciences.
Medford, Mass.-based startup Sofregen Medical Inc. has picked up $8 million in a series B round led by Anzu Partners LLC. The money is earmarked for continued development of Sofregen’s silk protein-based technology and for commercialization of its U.S. FDA-cleared Silk Voice for people with vocal cord problems.
New York-based startup 3Dbio Therapeutics snagged a rare pediatric disease designation from the U.S. FDA for Aurinovo, its investigational combination product for reconstruction of the outer ear in patients with microtia. The product offers an alternative to established treatments, none of which enable patients to regain an auricle comprising living tissue other than rib grafts, which are associated with significant donor site morbidity.
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea.
Menlo Park, Calif.-based startup Tusker Medical Inc. has received U.S. FDA approval to market its breakthrough-designated system for inserting tympanostomy tubes into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office. The Tula system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes and several devices for inserting the anesthetic and tubes into the ear drum. A low-level electrical charge delivers the anesthesia to the eardrum prior to tube placement, allowing for quick and needle-free numbing of the tympanic membrane.
BOGOTA, Colombia – A Costa Rican designer developed a system to create tailor-made molds to treat patients diagnosed with microtia, a congenital deformity, in which the external ear is not fully developed. "This is a very basic concept, and it really amazes me that it has not been implemented before," Andrés Quiros, the product designer behind the invention, told BioWorld MedTech.
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