Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet delivery device. New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. It marks the first approved fixed-dose combination of tropicamide and […]
Vision
Glaukos stock rises on 9% Q1 revenue growth
Glaukos (NYSE:GKOS) shares ticked up this morning on first-quarter results that came in mixed compared to the consensus forecast. Shares of GKOS rose 9% at $50.66 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped 0.03%. The (LOCATION)-based company posted losses […]
FDA clears iTrack Advance canaloplasty device from Nova Eye Medical
Nova Eye Medical announced today that it received FDA 510(k) clearance for its new iTrack Advance canaloplasty device. The FDA cleared iTrack Advance for microcatheterization and viscodilation to reduce intraocular pressure (IOP). It treats adult patients with primary open-angle glaucoma. Fremont, California-based Nova Eye designed its newest canaloplasty device to leverage the proprietary features of […]
Celanese to provide drug delivery platform for Glaukos glaucoma treatment
Celanese (NYSE:CE) announced today that it entered into an agreement with Glaukos (NYSE:GKOS) over drug delivery for glaucoma treatments. Dallas-based Celanese agreed to supply its VitalDose drug delivery platform for use as a component in Gluakos’ iDose TR. The iDose TR serves as a micro-invasive intraocular implant for lowering intraocular pressure. It treats patients with […]
Sight Sciences appoints new CFO
Sight Sciences (Nasdaq:SGHT) announced that it appointed Alison “Ali” Bauerlein as its chief financial officer and treasurer. Bauerlein’s appointment became effective on April 3. She joins from Inogen, having cofounded the medtech company in 2001 and served as CFO from 2009 through 2021. In that role, she oversaw the global finance and accounting functions, helping […]
Pixium Vision wins FDA breakthrough designation for dry AMD treatment device
Pixium Vision announced today that it received FDA breakthrough device designation for its Prima System for partially restoring vision. The Prima System, a photovoltaic substitute of photoreceptors, provides simultaneous use of the central prosthetic and peripheral natural vision. The company designed the implant for patients with atrophic dry age-related macular degeneration (AMD). It aims to […]
Staar Surgical appoints two new executives
Staar Surgical (Nasdaq:STAA) announced today that it appointed a new chief operating officer and chief clinical, regulatory and medical affairs officer. The Lake Forest, California-based implantable eye lens maker named Warren Foust as its new COO. Magda Michna takes over as chief clinical, regulatory and medical affairs officer. Staar’s global head of regulatory affairs, Denise […]
RxSight stock rises on Street-beating Q4
RxSight (Nasdaq:RXST) shares ticked up today on fourth-quarter results that came in ahead of the consensus forecast. Shares of RXST rose 1.1% at $15.85 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped 0.4%. The Aliso Viejo, California-based ophthalmic medical device maker […]
Glaukos submits FDA New Drug Application for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it submitted a New Drug Application (NDA) to the FDA for its iDose TR implant. Aliso Viejo, California-based Glaukos designed iDose TR as a micro-invasive intraocular implant. It continuously delivers therapeutic levels of a proprietary formulation of travoprost from within the eye over extended periods of time. Once all travoprost […]
Glaukos beats The Street in Q4
Glaukos (NYSE:GKOS) shares took a hit today despite fourth-quarter results that topped the consensus forecast. Shares of GKOS dipped 7% at $46.90 apiece in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 8.1%. The Aliso Viejo, California-based ophthalmic implant maker posted losses of […]
RightEye receives FDA warning that its product is a medical device
An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. The agency wrote in a letter, dated Dec. 20, 2022, that it inspected RightEye’s Bethesda, Maryland facility over 10 days in June and July 2022. In this inspection, it declared the RightEye Vision System a Class II Nystagmograph medical device. […]