Posts Tagged ‘Regulation’

“The Long and Winding Road”

“The Long and Winding Road”

The March 14th meeting of the FDA’s Ophthalmic Devices Panel Advisory Committee, which was convened by the FDA to consider the pre-market application (PMA) for STAAR Survival’s toric implantable collamer lens (TICL) brought to my mind the Beatles song “The Long and Winding Road” from their 1970 album “Let it Be.” The reason? It has…

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Physician Entrepreneurship in Ophthalmology

Physician Entrepreneurship in Ophthalmology

Striving to reach the aspiring entrepreneurs in the crowd at the 5th Annual Ophthalmology Innovation Summit @ AAO in New Orleans, Dick Lindstrom leads an experienced panel of entrepreneurs and tech developers through a series of focused questions. Sharing their highly coveted successes and failures, these panelists cover all aspects of entrepreneurship from focusing in…

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Developing an Effective Dialogue with the FDA

Developing an Effective Dialogue with the FDA

Moderating an informative conversation surrounding FDA procedures and communication, Emmett Cunningham, Summit Chairman, draws detailed responses from Wiley Chambers and Malvina Eydelman of the FDA. Focusing the discussion around common questions on how best to interact with the FDA, both formally and informally, Emmett helps deliver the specific answers attendees at the 5th Annual Ophthalmology…

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Going Public – Who, When, and Why?

Going Public – Who, When, and Why?

Detailing the grueling process and levels of determination necessary to go public, David Guyer, CEO for Ophthotech, begins this panel discussion with some of the more trying aspects of going public. Continuing to lead this distinguished panel through a IPO focused conversation, David stresses the importance of timing and perseverance throughout the planning and on…

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Novaliq Clears the Obstacles in Ocular Track Delivery

Novaliq Clears the Obstacles in Ocular Track Delivery

Bernhard Gunther, CEO for Novaliq GmbH, introduces their approach to improving topical ocular track delivery. Detailing the challenges involved, Bernhard expands on their unique opportunity to resolve these issues by dissolving poorly soluble tracks, with low viscosity and surface tension. Presenter: Bernhard Günther Bernhard Günther joined Novaliq as CEO in January 2007. He has more…

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Innovation in Ophthalmology Pushes Forward

Innovation in Ophthalmology Pushes Forward

SAN FRANCISCO — The future of innovation in ophthalmology is promising, with more forward movement than drag, according to a speaker here. “The tailwinds are stronger than the headwinds,” William J. Link, PhD, managing director of Versant Ventures, told colleagues interested in supporting innovation in the ophthalmic space at the Ophthalmology Innovation Summit. Key criteria…

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FDA – Medical Device Pathway: Tough Questions, Clear Answers

FDA – Medical Device Pathway Tough Questions, Clear Answers ASCRS 2013

Tackling some of the most difficult topics surrounding medical devices and approval with the FDA, Bill Link, Managing Director for Versant Ventures leads Malvina Eydelman, Director for the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, through an interview that brings her highly diverse and expert knowledge to the forefront for attendees of…

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