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 […]
Otolaryngology/Ear, Nose & Throat (ENT)
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 […]
Integra LifeSciences completes acquisition of J&J’s Acclarent
Integra LifeSciences announced that it completed its previously announced acquisition of Acclarent from Johnson & Johnson MedTech . Princeton, New Jersey-based Integra struck a deal with J&J to acquire Acclarent for $275 million upfront at the end of 2023. The deal also includes an additional $5 million upon the achievement of regulatory milestones. Acclarent, part […]
Haemonetics completes Attune Medical acquisition
Haemonetics announced today that it completed its previously announced acquisition of Attune Medical. Boston-based Haemonetics agreed to buy Attune for an upfront cash payment of $160 million just under a month ago. Chicago-based Attune medical develops the ensoETM proactive esophageal cooling device. The company designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These […]
Haemonetics agrees to acquire esophagus-protecting device maker Attune Medical
Haemonetics announced today that it entered into an agreement to acquire Attune Medical. Boston-based Haemonetics agreed to buy Attune for an upfront cash payment of $160 million. The deal also includes additional contingent consideration based on sales growth in the three years following the consummation of the acquisition. These additional payments also hinge on other […]
J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system
Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system. While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle […]
JVC launches FDA-cleared over-the-counter hearing aids
JVC today announced the commercial availability of its FDA-cleared, self-fitting, over-the-counter (OTC) hearing aids. Long Beach, California-based JVC jointly developed the hearing aids with health specialists Intricon and hearing aid company Tuned. They designed the AI-powered JVC EH-Z1500 Bluetooth-enabled hearing aids for a hassle-free self-fitting experience. The devices remove the need for an in-person visit. […]
Integra LifeSciences to buy Johnson & Johnson’s Acclarent and its ENT tech
Integra LifeSciences announced today that it entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech. Acclarent, part of J&J MedTech’s Ethicon unit, enhances Integra’s position in the ear, nose and throat (ENT) treatment market. Integra already offers the MicroFrance line of ENT instruments. The company believes that, upon closing, the deal […]
Hearing loss tech developer Envoy goes public in SPAC deal
Anzu Special Acquisition Corp. and Envoy Medical announced last week that they completed a previously announced business combination. The combination with Anzu, a special purpose acquisition company (SPAC) results in Envoy becoming a publicly listed company. It continues to operate under the name Envoy Medical. The company’s common stock commenced trading on the Nasdaq market […]
Galen Robotics wins FDA de novo nod for ear, nose, throat surgical robot
Galen Robotics announced today that the FDA granted it de novo classification for its Galen ES robotic surgery system. The de novo nod authorizes the use of Galen ES in rigid microlaryngeal procedures. Baltimore-based Galen Robotics designed the system as a cooperatively powered surgical assistant for ear, nose and throat (ENT) surgery. It facilitates ENT […]
Study backs esophagus-protecting device from Attune Medical
Attune Medical today announced positive data supporting the use of its ensoETM proactive esophageal cooling device. Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA investigational device exemption (IDE) for this indication just over one year ago. The […]