Devices and Diagnostics

Four Imaging and Diagnostic Platforms Making the Move Toward More Individualized Treatment

Imaging and diagnostics in ophthalmology are moving toward more individualized patient treatment, with quicker and more detailed diagnoses leading to improved and more specific treatment options. At a Breakfast Breakout session at OIS@ASCRS, presenters from four companies described innovations that are striving to achieve that goal. LacriScience’s LacriPen LacriScience is developing the LacriPen, a handheld…

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A Dozen Takeaways from OIS@ASCRS 2019

A Dozen Takeaways from OIS@ASCRS 2019

Last week’s OIS@ASCRS 2019 saw a record number of registrants, and the 650 attendees were treated to a wealth of information from the presenting companies, many on the dais for the first time at an Ophthalmology Innovation Summit. Here’s an even dozen takeaways. Vicken Karageozian, MD, president and CEO of Allegro Ophthalmics, gave a preview…

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Takeaway from FDA Imaging Forum: Need for Consensus Standards for Optical Coherence Tomography

FDA Forum Sounds Call for OCT Standards

Continued advances in optical coherence tomography are generating excitement for more precise and earlier diagnosis of eye disease, but more research and industry agreement on standards are needed, researchers and leading ophthalmologists told participants at a workshop convened by medical organizations and the Food and Drug Administration. OCT innovations were a primary point of discussion…

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Dr. Mark Blumenkranz Previews Panel on OCT Imaging and Forum on Laser-Based Imaging

Dr. Mark Blumenkranz Previews Panel on OCT Imaging and Forum on Laser-Based Imaging

Regulatory and reimbursement issues surrounding laser-based imaging modalities such as optical coherence tomography and adaptive optics, as well as the emerging role of artificial intelligence in ophthalmic imaging, will be the focus of a multi-disciplinary workshop with a host of medical organizations and the Food and Drug Administration April 8 in Silver Spring, MD, a…

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Parsing the Challenges of Reimbursement in the Glaucoma Space: Drug and Device Developers Address Elephant in the Room

Reimbursement Hurdles in Glaucoma Space

SAN FRANCISCO – When it comes to securing reimbursement models, ophthalmic device and drug developers are facing mounting pressure. Payers are demanding more evidence on a device’s or drug’s safety, efficacy, how it will work in the real world, and its cost-effectiveness. Device and drug companies have to prove value while continuing to foster innovation.…

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How Green Surgery Practices Are Reducing Greenhouse Gasses and Waste, and Cutting Costs

How Green Surgery Practices Are Reducing Greenhouse Gasses and Waste, and Cutting Costs

Surgery in most high-income countries generates large quantities of waste. For instance, single-use disposable instruments are often used in a variety of surgery settings, but they also create large amounts of waste1,2 – and in today’s move toward “greening” facilities, ambulatory surgery centers and hospitals are becoming more aware of and evaluating the amount of…

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Will Changes in the FDA’s 510(k) Process Be Good for Innovators?

Will Changes in the FDA’s 510(k) Process Be Good for Innovators?

Key players in the medical device industry, including one major player in ophthalmology, have issued mixed reviews in response to the Food and Drug Administration’s announced changes to the 510(k) clearance pathway for medical devices. The FDA says it’s undertaking the changes to bring its review and approval processes for medical devices into the 21st…

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The Sweet Six: Recipients of the 2018 Ophthalmology Innovation Awards

The Sweet Six: Recipients of the 2018 Ophthalmology Innovation Awards

The first Ophthalmology Innovation Awards were presented last night at the OIS-X Gala. Here’s a rundown of the award winners. Clinical Innovator: Ike Ahmed, MD Dr. Ahmed has been a leader in novel treatments for glaucoma, cataract, and lens implant surgery. His pioneering work in innovative glaucoma surgery includes coining the term microinvasive glaucoma surgery…

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