FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation. Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, […]
What should the Mann Foundation do next?
Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December. The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation […]
Notal Vision snags breakthrough designation for home OCT system
Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device. Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home […]
New eye health companies gain funders’ focus
Startups pioneering less-invasive technologies to treat common eye diseases are changing the outlook for both patients and the industry. A new study by CB Insights revealed that investors have been pouring money into smaller companies in 2017 and 2018, with some FDA approvals to begin marketing their technologies and treatments. These firms are eyeing conditions […]
Heidelberg Engineering wins FDA nod for upgraded eye imaging technology
The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases. OCTA is a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural OCT uses […]
BrainScope lands $4.5M to add vision assessment to its technology
The U.S. Department of Defense has awarded BrainScope a $4.5 million research contract to create and integrate ocular capabilities into its handheld, multi-parameter mild traumatic brain injury (mTBI) and concussion products. The Bethesda, Md.-based company’s initial product, BrainScope One, is the first FDA-cleared medical device that can assess the full spectrum of brain injury – from concussions (functional […]
Pixium Vision’s novel Prima chip helps patients see the light
Pixium Vision said today that its Prima miniature wireless photovoltaic sub-retinal implant has been activated in the first five patients. The patients all have severe vision loss from atrophic dry age-related macular degeneration. They are enrolled in a three-year clinical study in France to evaluate the safety and function of the Prima chip in eliciting visual […]
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