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 […]
Otolaryngology/Ear, Nose & Throat (ENT)
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 […]
Tivic Health regains Nasdaq compliance
Tivic Health (Nasdaq:TIVC) announced today that it regained compliance with the minimum bid price requirement on the Nasdaq market. Earlier this year, San Francisco-based Tivic filed an SEC Form 8-K pertaining to a notice of delisting from the Nasdaq market. The company received notice in January that its closing price fell below $1 for 30 […]
FDA authorizes Attune Medical’s ensoETM for use in RF ablation procedures
Attune Medical announced today that it received FDA de novo marketing authorization for its ensoETM device in ablation procedures. 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 […]
Lucid Hearing launches new over-the-counter hearing aids
Lucid Hearing announced today that it launched its Tala over-the-counter (OTC) hearing aid product line. Fort Worth, Texas-based Lucid Hearing designed Tala with Bluetooth-compatible wireless streaming. It also features patented LucidShape app-controlled, customizable profiles, a moisture-resistant coating and a rechargeable design. Its precision directional listening (PDL) system enhances the ability to hear speech and other […]
Tivic Health prices $1.4M common stock offering ahead of special stockholder meeting
Tivic Health (Nasdaq:TIVC) announced that it priced a public offering of common stock at $1.4 million. San Francisco-based Tivic intends to offer 33.173 million shares of common stock at $0.041 per share. The company plans to use the net proceeds for working capital and general corporate purposes. Tivic expects the offering to close on or […]