Posts Tagged ‘Regulation’

Gottlieb Brings VC Toolkit to FDA

Gottlieb Brings VC Toolkit to FDA

Soon-to-be FDA commissioner, Scott Gottlieb, MD, is well positioned to understand where the medtech and biotech communities are coming from. He’s been a partner at the venture capital fund New Enterprise Associates since he left the FDA in 2007, where he served as deputy FDA commissioner under President George W. Bush, and performed a stint…

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Device for Profoundly Blind Uses Tongue Electrodes

The profoundly blind form mental images of their surroundings from a variety of stimuli – touch, echo location, the their tip of cane or guide dog – and Wicab Inc. has developed a device that relays visual information via a neuro-stimulating array on the tongue to round out those images. Wicab president and CEO Robert…

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IOPtima Getting Traction in Europe, Asia

IOPtima Getting Traction in Europe, Asia

IOPtima CEO Ronan Castro gives OISTV an update on the company’s commerical launch of the IOPtimate system in Europe and Asia, including operations in China and Hong Kong. OPtima has developed the IOPtimate system; a unique laser based surgical system for the treatment of Glaucoma. The system utilizes a CO2 laser technology to reduce internal…

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Ophthalmic Innovation 2015 – “A View from the NEI”

Ophthalmic Innovation 2015 – “A View from the NEI”

Participant: Paul A. Sieving, MD, PhD Dr. Sieving became Director of the National Eye Institute after serving as the Paul R. Lichter Professor of Ophthalmic Genetics and founding director of the Center for Retinal and Macular Degeneration at the University of Michigan. View Full Profile

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RPS Diagnostics

RPS Diagnostics

RPS is a diagnostic company concentrating on inflammatory and infectious disease diagnoses; its flagship product, the InflammaDry, has been designed for in-office diagnosis of inflammatory conditions present in a patient’s eye. The company has devised two platforms: one, an amino-based platform using antibodies to detect disorders. The second, novel platform is a molecular test that…

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Ophthalmology Innovation Summit Gives Nod to Successful Public Start-ups

Ophthalmology Innovation Summit Gives Nod to Successful Public Start-ups

Largest ever gathering will showcase recent IPO Companies, early stage companies and speech by Allergan’s CEO LAS VEGAS, NV (PRWEB) NOVEMBER 12, 2015 The seventh annual Ophthalmology Innovation Summit today (OIS) will draw more than 900 clinicians, investors and executives upon the Planet Hollywood Hotel in Las Vegas for a glimpse of the world’s most…

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Premium IOLs: Two Outliers with Mainstream Potential

Premium IOLs: Two Outliers with Mainstream Potential

A problem that plagues refractive cataract surgery is the difficulty of determining the IOL power that will achieve each patient’s refractive target. In the old days, if a post-cataract patient wasn’t satisfied with their vision, they simply wore a pair of glasses. But patients paying thousands of dollars for a premium IOL are not satisfied…

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Imprimis’ Baum On Disrupting Compound Pharmacies

OIS Podcast

Imprimis Pharmaceuticals is disrupting the compound pharmaceutical industry, a segment of health care that’s undergoing significant regulatory upheaval. The company’s line of ophthalmology drugs could reduce or eliminate the need for post-surgical eye drops. Its approach is drawing support from many, including Dr. Richard Lindstrom, who serves on the company’s board. Podcast Transcript Tom Salemi:…

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Spotlight on Drug Delivery

Spotlight on Drug Delivery ASCRS 2015

“It’s becoming more like cage fighting than company building.” The Drug Delivery market is increasingly competitive. CEOs from the sector’s leading innovators Ocular Therapeutix, Kala Pharmaceuticals, Envisia Therapeutics and Icon Bioscience join in a discussion led by OIS Co-chair Emmett Cunningham, MD and K. Angela MacFarlane for ForSight Labs. Topics discussed including battling generics, protecting…

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Jade Therapeutics

Jade Therapeutics ASCRS 2015

Jade’s proprietary, cross-linked, bioerodable hydrogel technology can be used alone as an ocular lubricant, or as a sustained-release vehicle for either anterior or posterior segments. The thiolated carboxymethyl HA (CMHA-S) is “an improved version of the hyaluronic acid (HA) products on the market today for dry eye,” Klausner said. The technology can be produced as…

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ReVision Optics

Revision Optics ASCRS 2015

The Raindrop Near Vision Inlay has had three of the four modules submitted for the IDE, and the fourth is expected to be submitted some time in Q3 2015. Barring any unforeseen issues, that should put it on track for an Ophthalmic Panel discussion some time in the H1 2016, with a likely approval in…

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Aquesys

Aquesys ASCRS 2015

The XEN Gel Stent is made of a permanent, soft, collagen-derived, gelatin about 6 mm long. Upon implantation, it creates a gentle, diffuse outflow of aqueous from the anterior chamber into the non-dissected tissue of the subconjunctival space. The ab-interno procedure requires no tissue dissection or suturing. Although the device creates a bleb, there are…

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