Tears shed today by patients frustrated by an inability to obtain a diagnosis could speed diagnoses for others in the future. Researchers at Wenzhou Medical University, China, have developed a new nano membrane system, dubbed I-Tears, that harvests and purifies tiny droplets called exosomes from tears, allowing rapid analysis for disease biomarkers.
The FDA’s ability, or lack thereof, to churn out guidances is not always the stuff of industrial outrage, but manufacturers of laser-assisted in situ keratomileusis (LASIK) systems might find the timing of a new draft guidance on the procedure somewhat odd. The draft guidance arrives nearly a decade and a half after an April 2008 advisory hearing.
Abbvie Inc. and Istar Medical SA inked a deal to develop and commercialize Istar’s Miniject device to treat patients with primary open-angle glaucoma. The minimally invasive glaucoma surgical (MIGS) device won CE mark approval in November and has been available in some European countries since early 2022.
The U.S. FDA gave the greenlight to Acufocus Inc. for its IC-8 Apthera intraocular lens (IOL) for the treatment of cataracts. Like most other IOLs implanted as part of cataract surgery, the small aperture Apthera provides excellent distance vision. It distinguishes itself by also providing clear intermediate and near vision, essentially eliminating the blurring of close objects or words common as people age and develop presbyopia.
Forsight Robotics Ltd. amassed up to $55 million in series A financing led by Adani Group, with participation by existing investors Eclipse Ventures and Mithril Capital. The new funds will be used to further development of Forsight’s Oryom system, a surgical platform for fully robotic cataract surgery.
Ophthalmic and microsurgery device maker Carl Zeiss Meditec AG is investing in regenerative medicine startup Precise Bio Ltd. to jointly develop 4D bio-fabricated corneal transplants for diseases that require endothelial keratoplasty and natural lenticule transplants. Under the terms of the agreement, Carl Zeiss Meditec will lead a series B financing round in Precise Bio and fund development of two cornea transplant products.
Aldeyra Therapeutics Inc. CEO Todd Brady said that, with new data from a crossover trial with reproxalap in dry eye disease (DED), the question of “approvability has been put to bed,” and the company plans a pre-NDA meeting with U.S. FDA in the third quarter of this year.
Envision Technologies BV’s latest artificial intelligence (AI)-powered smart glasses for the blind and visually impaired are designed to help with reading, scanning faces and navigating everyday tasks. This visual assistant was introduced at California State University Northridge (CSUN) 2022 Assistive Technology Conference. Envision has updated its AI-based platform and ecosystem with improved optical character recognition (OCR) and better text recognition with contextual intelligence.
Meduni Vienna, the Medical University of Vienna, Austria, is working on a novel eye scanner combining the structural and functional sensitivity of optical coherence tomography (OCT) with the chemical specificity of Raman spectroscopy, to acquire data from the living human eye.
After more than 10 years on the market in Europe, Staar Surgical Co. can finally see a brighter future for its newest lenses in the U.S. This week, the company received FDA premarket supplement approval of its Evo/Evo+ Visian implantable lens for the correction of myopia and myopia with astigmatism in patients aged 21 to 45. Made of a proprietary poly(2-hydroxyethyl methacrylate)-based collagen co-polymer the company calls Collamer, the lens is inserted behind the iris in a quick procedure and can be removed, if needed. Unlike laser-assisted in situ keratomileusis (LASIK), the Evo procedure does not remove corneal tissue.
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