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.
Cochlear Ltd., of Sydney, received U.S. FDA approval for its Nucleus Profile Plus cochlear implant and the Nucleus 7 sound processor's new built-in connectivity, enabling direct streaming with compatible Android smartphones. The implant will be commercially available in the U.S. later this month.
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