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PERTH, Australia – Cochlear Ltd., of Sydney, is gearing up to launch its new Remote Check solution for cochlear implant users on the heels of an AU$880 million (US$559 million) capital raise and a patent battle loss that it plans to appeal.
PERTH, Australia – Cochlear Ltd., of Sydney, is gearing up to launch its new Remote Check solution for cochlear implant users on the heels of an AU$880 million (US$559 million) capital raise and a patent battle loss that it plans to appeal.
Aerin Medical Inc., an Austin, Texas-based company focused on minimally invasive solutions for chronic nasal conditions, has won U.S. FDA clearance for the Rhinaer Stylus to treat chronic rhinitis. The Rhinaer procedure can be performed under a local anesthetic in an ear, nose and throat (ENT) physician’s office, with no incisions and minimal discomfort.
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.
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