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Otolaryngology/Ear, Nose & Throat (ENT)

OtoNexus raises $9.8m

March 16, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Funding Roundup, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: OtoNexus Medical Technologies

Neuromod Devices appoints Elsaesser as CCO

March 11, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Neurological, Neuromodulation/Neurostimulation, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Neuromod Devices, Personnel Moves

Dianosic lands CE Mark for intranasal bleeding device

March 10, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Hospital Care, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: CE Mark, Dianosic

Aerin Medical wins FDA clearance for nonsurgical chronic rhinitis procedure

March 5, 2020 By Sean Whooley

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 […]

Filed Under: Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: Aerin Medical, FDA

Advanced Bionics recalls certain cochlear implants due to hearing degradation

March 2, 2020 By Sean Whooley

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 […]

Filed Under: Featured, Otolaryngology/Ear, Nose & Throat (ENT), Recalls, Regulatory/Compliance Tagged With: Advanced Bionics LLC, cochlear implant

Pavmed’s Lucid Diagnostics enters clinical trial with U of Penn

March 2, 2020 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Endoscopic, Featured, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Lucid Diagnostics, Pavmed, University of Pennsylvania

Intersect ENT’s Q4 beats Street despite losses

February 24, 2020 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Otolaryngology/Ear, Nose & Throat (ENT), Wall Street Beat Tagged With: Intersect ENT

PhotoniCare wins FDA nod for imaging tech to spot ear infections

January 6, 2020 By Sean Whooley

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Imaging, Otolaryngology/Ear, Nose & Throat (ENT), Pediatrics, Regulatory/Compliance Tagged With: PhotoniCare

Flexicare recalls fiber optic laryngoscope blades and handles

December 12, 2019 By Sean Whooley

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 […]

Filed Under: Featured, Otolaryngology/Ear, Nose & Throat (ENT), Recalls, Regulatory/Compliance Tagged With: Flexicare Medical

FDA clears Cochlear piezoelectric hearing implant

December 11, 2019 By Nancy Crotti

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Implants, Otolaryngology/Ear, Nose & Throat (ENT), Pediatrics Tagged With: Cochlear Ltd., FDA

3DBio Therapeutics wins FDA rare pediatric disease designation for outer ear reconstruction

December 6, 2019 By Sean Whooley

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: 3DBio Therapeutics

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