OtoNexus Medical Technologies filed an amendment to its SEC Form D last week to confirm the sale of nearly $10 million in an equity offering. The Seattle-based ultrasound technology maker sold approximately $9.77 million of an $18.2 million offering, leaving just over $8.4 million remaining to be sold, according to the filing. OtoNexus made the […]
Otolaryngology/Ear, Nose & Throat (ENT)
Neuromod Devices appoints Elsaesser as CCO
Non-invasive neuromodulation technology developer Neuromod Devices announced today that it is appointing Florian Elsaesser as its new chief commercial officer. Elsaesser is a 12-year veteran in the space, having worked extensively in the hearing aid industry, according to a news release. He previously held executive positions at Sivantos and Siemens (NYSE:SI) Audiology. Dublin-based Neuromod Devices said […]
Dianosic lands CE Mark for intranasal bleeding device
Startup Dianosic (Strasbourg, France) announced today that it has obtained the CE Mark for CAVI-T, a low-pressure asymmetric balloon for treating spontaneous and post-operative intranasal bleeding. CAVI-T is the first asymmetric intranasal balloon that stops bleeding by applying low-force compression while adapting to the anatomy of the nasal fossa, according to the company. The balloon […]
Aerin Medical wins FDA clearance for nonsurgical chronic rhinitis procedure
Aerin Medical announced today that it won FDA clearance for its RhinAer Stylus for nonsurgical treatment of chronic rhinitis. RhinAer Stylus is designed to directly disrupt the signals that cause symptoms of nonallergic rhinitis through Aerin’s proprietary temperature-controlled technology that goes through the nasal airway to provide a therapeutic effect while minimizing risk to surrounding […]
Advanced Bionics recalls certain cochlear implants due to hearing degradation
Advanced Bionics announced a voluntary recall of the initial version of its HiRes Ultra and Ultra 3D cochlear implant devices due to a decrease in performance experienced by some recipients. The company has experienced recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of Feb. 11, in […]
Pavmed’s Lucid Diagnostics enters clinical trial with U of Penn
Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics entered into a clinical trial research agreement with the University of Pennsylvania to observe its EsoCheck esophageal cell collection device. EsoCheck with “collect & protect technology” is designed to offer a less invasive, more efficient and cost-effective alternative to endoscopic biopsies when managing patients with eosinophilic […]
Intersect ENT’s Q4 beats Street despite losses
Intersect ENT (NSDQ:XENT) shares dipped today on fourth-quarter losses that topped the consensus forecast. The Menlo Park, Calif.-based ear, nose and throat condition treatment developer posted losses of -$7.96 million, or -25¢ per share, on sales of $31.75 million for the three months ended Dec. 31, 2019, for a nearly $3 million bottom-line slide on a […]
PhotoniCare wins FDA nod for imaging tech to spot ear infections
PhotoniCare announced today that it won FDA 510(k) clearance for its TOMi Scope for non-invasive imaging of the middle ear to spot ear infections and more. The TOMi Scope is designed to determine the presence or absence of fluid in the middle ear, as well as to characterize the fluid type, by using optical coherence […]
Flexicare recalls fiber optic laryngoscope blades and handles
Flexicare Medical today issued a recall for its BritePro Solo and BriteBlade Pro single-use fiber optic laryngoscope blades and handles due to a risk of choking. According to a medical device alert pertaining to England, Scotland, Wales and Northern Ireland, the BritePro Solo and BriteBlade Pro contain loose bearings and a retaining ring that may […]
FDA clears Cochlear piezoelectric hearing implant
The FDA has cleared a second-generation pioezoelectric bone-conduction hearing implant from Cochlear (ASX:COH), the company announced today. The Osia 2 system is an active osseointegrated, steady-state implant (OSI) that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear. It is designed to […]
3DBio Therapeutics wins FDA rare pediatric disease designation for outer ear reconstruction
3DBio Therapeutics announced today that the FDA granted it rare pediatric disease designation for the AuriNovo outer ear reconstruction system for patients with microtia. According to the New York–based company, there are currently no other established treatments for microtia that allow a patient to regain an auricle comprising living tissue aside from limited rib grafts […]
