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Otolaryngology/Ear, Nose & Throat (ENT)

Lyra Therapeutics appoints new chief medical officer

July 5, 2022 By Sean Whooley

Lyra Therapeutics (Nasdaq:LYRA) announced today that it appointed Dr. Richard Nieman as its new chief medical officer (CMO). Nieman’s appointment as CMO of Lyra, which develops the XTreo — a platform for enabling precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues — will be made […]

Filed Under: Business/Financial News, Drug-Device Combinations, Implants, Otolaryngology/Ear, Nose & Throat (ENT), Pharmaceutical, Respiratory Tagged With: Lyra Therapeutics, Personnel Moves

Aerin Medical reports positive 4-year results for VivAer treatment

June 29, 2022 By Sean Whooley

Aerin Medical today announced published results from a four-year clinical trial of its VivAer treatment for nasal airway obstruction (NAO). Sunnyvale, California–based Aerin designed VivAer, which holds both CE mark and FDA 510(k) approval, to use patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the […]

Filed Under: Clinical Trials, Featured, News Well, Otolaryngology/Ear, Nose & Throat (ENT), Respiratory Tagged With: Aerin Medical

Envoy Medical wins FDA IDE for Acclaim cochlear implant

June 21, 2022 By Sean Whooley

Envoy Medical announced today that it received FDA investigational device exemption (IDE) for its Acclaim cochlear implant. White Bear Lake, Minnesota–based Envoy Medical will begin a single-center IDE early feasibility study with the fully implanted Acclaim cochlear implant at Mayo Clinic in Rochester, Minnesota. The company said in a news release that its Acclaim implant […]

Filed Under: News Well, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: Envoy Medical Corp.

Aerin Medical closes $60M equity financing

June 16, 2022 By Sean Whooley

Ear nose and throat (ENT) treatment technology developer Aerin Medical announced today that it closed a $60 million equity financing. Sunnyvale, California-based Aerin’s financing was led by new investor Ally Bridge Group with participation from all existing major investors, including KCK MedTech, Questa Capital and OrbiMed. According to a news release, Aerin Medical intends to […]

Filed Under: Business/Financial News, Featured, Funding Roundup, Otolaryngology/Ear, Nose & Throat (ENT), Radiosurgery/Radiation therapy, Respiratory Tagged With: Aerin Medical

Two-year data backs Aerin Medical’s chronic rhinitis treatment

June 7, 2022 By Sean Whooley

Aerin Medical announced today that a study of its RhinAer technology demonstrated success in treating chronic rhinitis patients. Sunnyvale, California–based Aerin Medical — one of MassDevice’s 20 medical device startups you need to know in 2020 — designed its RhinAer temperature-controlled radiofrequency (RF) technology to disrupt nerve signals that cause chronic rhinitis symptoms, including constant runny […]

Filed Under: Clinical Trials, Otolaryngology/Ear, Nose & Throat (ENT), Radiosurgery/Radiation therapy, Respiratory Tagged With: Aerin Medical

Medtronic completes Intersect ENT acquisition

May 13, 2022 By Sean Whooley

Medtronic (NYSE:MDT) announced that it completed its previously announced $1.1 billion acquisition of Intersect ENT (Nasdaq:XENT). Fridley, Minnesota-based Medtronic announced in August 2021 that it would acquire all outstanding shares of the Menlo Park, California-based sinus implant maker for $28.25 per share in an all-cash transaction. As a result of the transaction, Medtronic acquires Intersect […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Implants, Mergers & Acquisitions, News Well, Otolaryngology/Ear, Nose & Throat (ENT) Tagged With: Intersect ENT, Medtronic

FDA warns of risk from Medtronic silicone-based EMG endotracheal tubes

May 2, 2022 By Jim Hammerand

The FDA is evaluating the risk of Medtronic (NYSE:MDT) silicone-based electromyogram (EMG) endotracheal tubes following reports of deaths and serious adverse events. The FDA issued the warning last week in a letter to healthcare providers concerning the Medtronic NIM Standard Reinforced EMG Endotracheal Tubes and Medtronic NIM Contact Reinforced EMG Endotracheal Tubes. They are the only silicone-based EMG […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), News Well, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance, Respiratory, Surgical Tagged With: FDA, Medtronic

Impel NeuroPharma rebrands to Impel Pharmaceuticals as part of corporate transformation

April 25, 2022 By Sean Whooley

Impel NeuroPharma (Nasdaq:IMPL) announced today that it changed its name to Impel Pharmaceuticals as part of a corporate rebrand. Seattle-based Impel develops proprietary Precision Olfactory Delivery (POD) technology to treat patients suffering from diseases across a range of areas — and the central nervous system. The company’s Trudhesa nasal spray for treating migraine in adults received […]

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations, Neurological, Otolaryngology/Ear, Nose & Throat (ENT), Pharmaceutical Tagged With: Impel Neuropharma, Impel Pharmaceuticals

DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

April 25, 2022 By Jim Hammerand

Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial […]

Filed Under: Blog, Business/Financial News, Featured, Food & Drug Administration (FDA), Legal News, News Well, Otolaryngology/Ear, Nose & Throat (ENT), Recalls, Regulatory/Compliance, Respiratory Tagged With: Department of Justice, FDA, Philips, Philips Respironics, Respironics, Royal Philips

Lyra Therapeutics closes $100.5M private placement

April 13, 2022 By Sean Whooley

Lyra Therapeutics (Nasdaq:LYRA) announced today that it closed its previously announced private placement worth $100.5 million. The company announced last week that, in the private placement, investors had the option to purchase either shares of Lyra’s common stock at $4.22 per share or, in lieu thereof, pre-funded warrants to purchase shares of common stock with an […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Implants, News Well, Otolaryngology/Ear, Nose & Throat (ENT), Pharmaceutical, Respiratory Tagged With: Lyra Therapeutics

Lyra Therapeutics announces $100.5M private placement

April 8, 2022 By Sean Whooley

Lyra Therapeutics (Nasdaq:LYRA) announced today that it agreed to sell securities in a private placement worth more than $100 million. The company — which develops the XTreo platform designed to enable precise, sustained, and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues — did not list an intended use […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Funding Roundup, Implants, News Well, Otolaryngology/Ear, Nose & Throat (ENT), Respiratory Tagged With: Lyra Therapeutics

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