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ReVision Optics Inc.

FDA slaps Class 1 designation on corneal implant recall

March 6, 2019 By Nancy Crotti

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, […]

Filed Under: Featured, Food & Drug Administration (FDA), Implants, News Well, Optical/Ophthalmic, Regulatory/Compliance, Vision Tagged With: FDA, ReVision Optics Inc., RVO 2.0

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

January 15, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News, Featured Tagged With: apyxmedical, biogennix, Cardiac Dimensions, Cardiovascular Systems Inc., Coorstek, Covidien, DaVita Inc., Digirad Corp., Endologix, ev3 Inc., Integra LifeSciences, Intuitive Surgical, InVivo Therapeutics, JenaValve, Johnson and Johnson, Medtronic, mentice, Micrus Endovascular Corp., Natus Medical Inc., Outset Medical, Patterson Companies, ReVision Optics Inc., Solace Therapeutics, Sonova Holding AG, Xtant Medical

FDA warns on corneal haze with recalled Raindrop inlay

October 24, 2018 By Brad Perriello

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Recalls, Regulatory/Compliance Tagged With: ReVision Optics Inc.

ReVision Optics raises $32m for Raindrop nearsightedness inlay

November 10, 2016 By Brad Perriello

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 […]

Filed Under: Funding Roundup, Optical/Ophthalmic, Wall Street Beat Tagged With: ReVision Optics Inc.

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

August 18, 2016 By Brad Perriello

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. […]

Filed Under: Funding Roundup, Optical/Ophthalmic, Wall Street Beat Tagged With: Pacific Western Bank, ReVision Optics Inc., Square 1 Bank

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

August 12, 2016 By Fink Densford

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 […]

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Filed Under: Business/Financial News Tagged With: Allergan, CeloNova BioSciences, Cerus Corp., CooperVision, Endologix, InVivo Therapeutics, Medtronic, Personnel Moves, ReVision Optics Inc., Seno Medical Instruments, TriVascular, UnitedHealth Group

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

August 4, 2016 By Fink Densford

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 […]

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Filed Under: Business/Financial News Tagged With: Bausch + Lomb, Covidien, Danaher Corp., Haemonetics, LivaNova, Medtronic, Pavmed, Personnel Moves, Radiology Protocols, ReVision Optics Inc., Zimmer Biomet

ReVision Optics touts Raindrop inlay study data

August 1, 2016 By Fink Densford

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 […]

Filed Under: Clinical Trials, Optical/Ophthalmic Tagged With: ReVision Optics Inc.

FDA approves Raindrop presbyopia inlay from ReVision Optics

June 30, 2016 By Brad Perriello

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 […]

Filed Under: Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance Tagged With: ReVision Optics Inc.

ReVision Optics touts 1-year data for Raindrop inlay

March 9, 2016 By Fink Densford

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 […]

Filed Under: Clinical Trials, Optical/Ophthalmic Tagged With: ReVision Optics Inc.

ReVision touts visual acuity data from Raindrop trial

December 16, 2015 By Fink Densford

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 […]

Filed Under: Clinical Trials, Optical/Ophthalmic Tagged With: ReVision Optics Inc.

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