Olympus announced today that it launched Visera S, its new all-in-one imaging platform that features stroboscopy. Tokyo-based Olympus’ new video platform integrates advanced diagnostic capabilities, including narrow-band imaging (NBI) technology. It forms part of the company’s expanding ear, nose and throat (ENT) portfolio of solutions. The company designed it to improve ENT diagnostic efficiency and […]
Otolaryngology/Ear, Nose & Throat (ENT)
FDA authorizes OTC hearing aid software for Apple AirPods
The FDA announced today that it authorized the first over-the-counter (OTC) hearing aid software device, made by tech giant Apple. Apple last week unveiled new health features for some of its technologies, including the “Hearing Aid Feature” for its AirPods Pro headphones. Once installed and customized to the user’s needs, the feature enables compatible versions […]
Apple introduces new sleep apnea, hearing aid features on Watch, AirPods
Apple today unveiled new sleep and hearing health features for its Apple Watch and AirPods Pro 2, expanding its health metrics offerings. The Apple Watch now offers sleep apnea notifications, utilizing the tech giant’s new breathing disturbances metric. Apple says it expects FDA authorization soon, along with approval in other geographies. The company plans to […]
Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
The FDA issued a notice deeming a recall of Medtronic McGrath Mac video laryngoscopes Class I, the most serious kind. This recall involves removing certain devices from where they are used or sold as the device may cause serious injury or death if people continue using it. It also includes updating instructions for using other […]
Neurostim company Phagenesis picks new CEO
Phagenesis, a developer of neurostimulation for treating swallowing dysfunction announced today that it appointed Chad Hoskins as CEO. A seasoned executive, Hoskins brings decades of experience scaling therapies, driving U.S. growth and delivering on strategic objectives. He joins the company around six months after it raised $42 million in a Series D financing round. The […]
FDA expands labeling for Linx reflux management system from J&J’s Ethicon
J&J MedTech’s Ethicon announced today that it received expanded FDA labeling for its Linx reflux management system. The new FDA labeling expands Linx’s availability to include patients with Barrett’s esophagus (BE) experiencing gastroesophageal reflux disease (GERD) symptoms. The FDA based its decision on a retrospective review of a 2021 study that found Linx safe and […]
Karl Storz’s AventaMed wins FDA nod for ear tube placement device
AventaMed, a Karl Storz company, announced that it received FDA 510(k) clearance for its Solo+ ear tube placement system. Solo+ combines multiple steps into an all-in-one device for a simplified approach to enable office-based pediatric tympanostomies. To date, ear tube placement typically takes place in an operating room and requires general anesthesia. The company designed […]
FDA clears Oticon Medical’s hearing loss implant
Oticon Medical announced today that the FDA granted clearance for its Sentio transcutaneous bone conduction hearing system. The system includes the Sentio 1 Mini external sound processor and Sentio Ti implant, placed under the skin. Askim, Sweden-based Oticon says it’s the smallest transcutaneous bone conduction hearing system to date. The company says it delivers the […]
Smiths Medical warns on some Bivona tracheostomy tubes, death reported
ICU Medical’s Smiths Medical issued an urgent field safety notice to warn of a potential defect with some of its Bivona tracheostomy products. Posted out of Germany, the warning applies to a number of Bivona neonatal/pediatric and adult tracheostomy tubes. That includes the Aire-Cuf, TTS, Uncuffed and Mid-Range Bivona tubes for neonatal/pediatric uses. For adults, […]
OM1, Medtronic partner on drug-eluting implant study
OM1 today announced positive results from its partnership with Medtronic (NYSE:MDT) evaluating the Propel corticosteroid-eluting implants. The Propel bioabsorbable implant family came to Medtronic through its acquisition of IntersectENT in 2022. OM1 and Medtronic partnered on their study to focus on healthcare resource use and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent […]
FDA clears Spirair’s SeptAlign system to treat nasal septal deviation
Spirair today announced it received FDA 510(k) clearance for its SeptAlign system to treat nasal septal deviation. The SeptAlign system uses the company’s bioabsorbable implant to straighten minor cartilaginous septal deviation. The implant won FDA clearance in August 2023. Nasal septal devition is one of the most common causes of nasal airway obstruction, making breathing […]