The FDA today said it granted de novo clearance to a self-fitted hearing aid made by Bose Corp. for adults with mild to moderate hearing loss. The Bose Hearing Aid is designed to allow the patient to fit, program and control the hearing aid without help from a healthcare provider, the first such device on the […]
Inside Spirox: The challenges and successes of a physician-entrepreneur
This is the first podcast in a series produced with MPR, a product development firm that thrives on creating breakthrough products. Thanks for listening and we hope you enjoy this interview with physician-entrepreneur Dr. Iyad Saidi. The story of Spirox and its bioresorbable nasal implant is one of great success – the company sold to […]
Frequency completes enrollment in safety trial for hearing loss drug
Frequency Therapeutics said today that it finished enrolling participants in a single-dose safety trial for its FX-322 hearing loss drug candidate. The company’s drug candidate emerged as part of its Progenitor Cell Activation platform – the combination of small molecules are designed to activate progenitor cells and trigger the formation of new hair cells in the […]
Anthem adds Intersect ENT’s Sinuva implant to formulary
Anthem this month added Intersect ENT‘s (NSDQ:XENT) Sinuva steroid-releasing implant to its updated formulary as a Tier 3 product, according to a note from Leerink analysts. The product is designated on Anthem’s formulary as “LD” – limited distribution – and is only available to certain pharmacies or wholesalers. Intersect ENT launched the product in the U.S. in April this year. Get the […]
Advanced Bionics wins FDA nod for MRI-safe HiRes Ultra 3D cochlear implant
Sonova Holding AG (SIX:SOON) subsidiary Advanced Bionics said yesterday that it won FDA approval for its HiRes Ultra 3D cochlear implant. The newly approved implant is cleared for use during magnetic resonance imaging examinations as it features a new magnet design which provides alignment with an external magnetic field in any direction. The magnet allows users […]
GN Hearing inks deal with Google, launches Beltone Amaze
GN Hearing (CPH:GN) this week announced it inked a partnership with Google (NSDQ:GOOG) to enable its hearing aid devices to directly stream audio from Android devices, and said it launched its Beltone Amaze hearing solution. With the Google deal, users will be able to connect and monitor their hearing aids on Android devices as well as […]
Frequency Therapeutics launches clinical trial for hearing loss drug
Frequency Therapeutics said today that the first patients have been treated in a Phase I/II clinical trial to assess its first-in-class drug candidate for hearing restoration. The 24-patient trial is slated to include people with stable sensorineural hearing loss. Participants will receive an injection of Frequency’s FX-322 or a placebo in one ear, with a follow-up visit […]
Intersect ENT shares tumble on Q2 results
Shares in Intersect ENT (NSDQ:XENT) fell today after the medical device maker missed sales expectations on Wall Street with its second-quarter financial results. The Menlo Park, Calif.-based company posted a net loss of -$4.2 million on sales of $26.3 million for the 3 months ended June 30, for sales growth of 9.7% compared with the same period […]
FDA grants de novo clearance to Med-El for Bonebridge hearing implant system
Cochlear implant maker Med-El USA said yesterday it won FDA de novo clearance for its Bonebridge bone conducting hearing implant system, with plans to launch the device this year. The newly cleared system is indicated for individuals 12 years and older with conductive hearing loss, mixed hearing loss or single-sided deafness, the Durham, N.C.-based company said. The […]
EndoGastric Solutions raises $25m
EndoGastric Solutions has raised $25.4 million in equity from 28 investors as part of a $35.5 million offering, according to a document filed with the SEC this week. The Washington-based company has not yet publicly stated what it plans to do with its newly-acquired funds. EndoGastric Solutions sells a device designed to reconstruct the gastroesophageal […]
Cochlear launches Nucleus app for Android devices
Cochlear Ltd. (ASX:COH) said today it launched a Google (NSDQ:GOOG) Android compatible version of its Nucleus smart application designed for use with its Nucleus 7 sound processor. With the update, users of the Nucleus 7 with Android devices can control their hearing through the linked application, and will gain access to a number of new features previously […]
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