ENT Devices Companies

Top Industry Leaders in the ENT Devices Market

Latest ENT Devices Companies Update

October 2023: The US Food and Drug Administration (FDA) granted Galen Robotics authorization and a De Novo classification grant for the Galen ES Robotic System. With the authorization, the device may be marketed for application in rigid microlaryngeal procedures. The purpose of the novel surgical assist device powered cooperatively is to facilitate ear, nose, and throat (ENT) procedures. ENT surgical procedures, such as instrument implantation and the utilization of microlaryngeal alligator forceps, are within its scopes. The instrument is precisely and steadily positioned by the device in accordance with the surgeon's movements; the surgeon retains direct physical control over the instrument throughout. Additionally, Galen ES offers the possibility of instrument stability during critical microlaryngeal procedures. Its objective is to improve patient outcomes through the provision of sophisticated features and rapid setup time that augment the capabilities of otolaryngologists.

January 2023: EndoTheia Inc., a medical device company headquartered in the US, received a Breakthrough Device designation from the FDA in January 2023. This designation grants the company priority status with the FDA for its technology, which significantly enhances minimally invasive flexible endoscopic surgery. This designation has been bestowed upon only the seventh device in the category of Ear Nose and Throat (ENT) devices in history. The designation will facilitate the regulatory process, allowing EndoTheia to introduce its innovative solution to physicians and patients in a timely manner. This technological advancement utilizes laser-machined metallic tubes with exceptionally thin walls to fabricate steerable, highly flexible devices capable of traversing conventional endoscopes while simultaneously housing interventional instruments. The provision of steerability to endoscope-delivered instruments by these devices paves the way for novel therapeutic and diagnostic applications of flexible endoscopy.

List of ENT Devices Key companies in the market