Latest Industry News & Trends
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Device News
US FDA Clears Tixel i Dry Eye and MGD Treatment Device from Novoxel
Israel’s Novoxel announced Nov. 19 that the US FDA had granted 510(k) clearance to the Tixel i treatment device for evaporative dry eye and meibomian gland dysfunction. The company said the device ...
US FDA Grants De Novo Classification to LumiThera’s System for Dry AMD
LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobio-modulation system for treatment of patients with dry age-related macu...
AAO and Eyecelerator Sessions Showcase Latest in Glaucoma Lasers and Surgical Devices
New glaucoma lasers and surgical devices were shown at various venues during the 2024 AAO meeting, including Glaucoma Subspecialty Day and the Eyecelerator meeting. There was also an important upda...
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...
US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD
LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobiomodulation system for treatment of patients with dry age-related macul...
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...
Zeiss Begins Broad US Rollout of Micor 700 for Phaco-less Cataract Surgery
Zeiss Medical Technology reported Sept. 26 that it had begun broad US distribution of the Micor 700, the first hand-held device to extract a crystalline lens in cataract surgery without the need fo...
FDA Names New Leaders at OPEQ and CDHR
Ross Segan, MD, MBA, FACS, has become director of the US FDA’s Office of Product Evaluation and Quality (OPEQ). The office, part of FDA’s Center for Devices and Radiological Health (CDRH), oversees...
Ross Segan, MD, MBA, FACS, Takes Helm of FDA’s OPEQ
Ross Segan, MD, MBA, FACS, has becomedirector of the US FDA’s Office of Product Evaluation and Quality (OPEQ). The office, part of FDA’s Center for Devices and Radiological Health (CDRH), oversees ...
Injectsense Reports First Human Implantation of Ultraminiature IOP Sensor
Injectsense, of Emeryville, California, announced Aug. 27 that it had implanted its first ultraminiature wireless sensor for measuring intraocular pressure (IOP). Glaucoma specialist Juan Mura, MD,...
LumiThera Gains CPT Code to Report Retinal PBM Therapy, a Step Toward Reimbursement
LumiThera announced Aug. 7 that a new Category III CPT code had been established, effective Jan. 1, 2025, to report “Photobiomodulation therapy of retina, single session.” The company said the code...
Multitude of Novel Glaucoma Surgery Devices to Drive Procedure Growth
The goal of a growing number of companies entering the already crowded glaucoma device market is to provide surgical treatment options with greater safety and effectiveness. Thirty-six products are...
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain De Novo Certification for Marketing
Balance Ophthalmics has gained US FDA de novo classification for its FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system, a goggles and pump system designed to lower intraocular pressure (IOP) i...
Ophthalmic Devices to be Included in FDA TAP Accelerator Program
The US FDA announced July 1 that it was expanding its TAP pilot program in October to include ophthalmic devices, as well as radiological health devices. The voluntary program, officially named the...
Ophthalmic Devices to be Included in FDA TAP Program
The US FDA announced July 1 that it was expanding its TAP pilot program in October to include ophthalmic devices, as well as radiological health devices. The voluntary program, officially named the...
IOP-Lowering Goggles Developed by John Berdahl, MD, Gain De Novo Nod for Marketing
Balance Ophthalmics has gained US FDA de novo classification for its FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system, a goggles and pump system designed to lower intraocular pressure (IOP) i...
Ophthalmic Company Revenue Totals $11 Billion, a Drop of 0.2 Percent, in Q1-2024
Ophthalmic manufacturer revenue in Q1-2024 totaled $11.0 billion. Revenue decreased 0.2 percent from the same quarter in 2023 and dropped 1.7 percent from Q4-2023. The total includes Market Scope e...
Innovations on Horizon are Expected to Rejuvenate Cataract Equipment Market
Signs of innovation and renewal can be found in all segments of the cataract equipment market, despite evidence that the market has become mature. Innovation looms in next-generation ultrasonic pha...
LambdaVision Reports First Closing of Seed Round to Advance Artificial Retina
LambdaVision, of Farmington, Connecticut, reported May 29 that it had secured the first closing of a seed round, let by Aurelia Foundry Fund, a fund spun out of Massachusetts Institute of Technolog...
Ophthalmic Company Revenue in Q4-2023 Rises 0.4 Percent
Ophthalmic manufacturer revenue in Q4-2023 totaled $11.2 billion. Revenue increased 0.4 percent from the same quarter in 2022 and increased 1.0 percent from Q3-2023. The total includes Market Scope...
Retinal Device Market Awaits Technological Impact of Zeiss’ DORC Acquisition
Carl Zeiss Meditec’s acquisition of DORC (Dutch Ophthalmic Research Center) will change the players in the retinal surgical equipment market, but whether it will lead to any major changes in market...
Ophthalmic Company Revenue Increases 3.4 Percent in Third Quarter of 2023
Ophthalmic manufacturer revenue in Q3-2023 totaled $11.1 billion. Revenue increased 3.4 percent from the same quarter in 2022 and decreased 2.7 percent from Q2-2023. The total includes Market Scope...
Select US FDA Approvals and Clearances in November 2023
The US FDA granted three clearances through the ophthalmic device division using the 510(k) pathway in November 2023, according to the agency’s database. Medimaging Integrated Solution (MiiS) recei...
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