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FDA slaps Class 1 designation on corneal implant recall

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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, […]

JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019

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JenaValve Technology said today that it named former ReVision Optics prez & CEO John Kilcoyne as its new chief executive officer, effective immediately, replacing Dr. Victoria Carr-Brendell, who has taken up an executive leadership position with Sonova Holding AG (SIX:SOON). Prior to his time at ReVision Optics, Kilcoyne served as prez & CEO at Micrus Endovascular where he […]

FDA warns on corneal haze with recalled Raindrop inlay

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The FDA is warning about the Raindrop corneal inlay developed by now-fefunct ReVision Optics after 75% of patients in a post-approval surveillance study developed corneal hazing. Lake Forest, Calif.-based ReVision won pre-market approval from the FDA in June 2016 for the Raindrop inlay to treat presbyopia. The device is a microscopic hydrogel inlay placed in the cornea of the […]

ReVision Optics raises $32m for Raindrop nearsightedness inlay

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ReVision Optics said today that it raised $32 million in an equity round to back the commercialization of its Raindrop near-vision inlay. Existing backers Canaan Partners, Domain Associates, InterWest Partners and ProQuest Investments also participated in the round, Lake Forest, Calif.-based ReVision said. The Raindrop inlay, which won pre-market approval from the FDA in June, is a […]

ReVision Optics takes out $10m credit line for Raindrop inlay

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ReVision Optics said today that it took out a $10 million credit line with Pacific Western Bank subsidiary Square 1 Bank as it looks to build out its commercial operation after winning FDA approval for its Raindrop presbyopia inlay. The Raindrop inlay, a corneal implant designed to treat nearsightedness, won pre-market approval from the FDA in June. […]

Seno Medical grabs ex-CeloNova CFO Davis | Personnel Moves August 12, 2016

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Seno Medical grabs ex-CeloNova CFO Davis Seno Medical Instuments said this week it tapped former CeloNova BioSciences chief financial officer Eric Davis to take over the CFO role at Seno Medical. Prior to his years at CeloNova, Davis operated as CFO and operating officer at Genesis Networks Enterprises. Seno Medical said that Davis has more than […]

Haemonetics taps ex-Medtronic CIO Burke as new CFO | Personnel Moves August 4, 2016

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Haemonetics taps ex-Medtronic CIO Burke as new CFO   Haemonetics (NYSE:HAE) said this week it tapped former Medtronic (NYSE:MDT) chief integration officer William Burke as its new chief financial officer, effective August 8. Burker operated as CIO with Medtronic since 2015, serving during the integration of Covidien. Prior to that, he held various finance positions with […]

ReVision Optics touts Raindrop inlay study data

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ReVision Optics today released results from a trial of its Raindrop near vision inlay, touting significantly improved near and immediate vision and no loss of distance binocular acuity in subjects with presbyopia. The study was published in the journal Investigative Ophthalmology and Visual Science, the company said. “This newly published study shows that changes in […]

FDA approves Raindrop presbyopia inlay from ReVision Optics

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ReVision Optics won pre-market approval from the FDA yesterday for its Raindrop near vision inlay, a corneal implant designed to treat presbyopia. The Raindrop is a microscopic hydrogel inlay placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to gently reshape the anterior curvature of the cornea to provide near and intermediate […]

ReVision Optics touts 1-year data for Raindrop inlay

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ReVision Optics said today that 1-year results from the Phase III FDA clinical study of its Raindrop Near Vision Inlay designed for treating presbyopia indicated a 92% rate of satisfaction among study subjects. The outcomes data was published in the journal Ophthalmology this month. The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake […]

ReVision touts visual acuity data from Raindrop trial

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ReVision Optics today released data from a trial of its Raindrop implantable presbyopia-correcting corneal inlay, touting high rates of near visual acuity in treated patients versus untreated patients. Data from the 344-patient trial was presented at the 2015 Opthalmology Innovation Summit in Las Vegas last month, the company said. “We are clearly seeing outstanding visual […]

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