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Regulatory/Legislative News
Glaukos submits IDE application for iStent infinite three-stent system
Glaukos Corporation has submitted an investigational device exemption application to the FDA to study the iStent infinite trabecular micro-bypass system, a three-stent device designed to reduce IOP in cases of refractory glaucoma in a standalone procedure, according to a company press release.
BLOG: Backdoor health care reform
On Dec. 22, President Donald J. Trump signed the “Tax Cuts and Jobs Act” into law. This law, designed and passed by the 115th Congress, is purported to provide a major change in the American tax structure to promote jobs and “rev up” the economy.
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Luxturna, Rhopressa approvals lead FDA's recent ophthalmology news
In recent weeks, the FDA has issued three approvals for ophthalmic indications and multiple other rulings regarding ophthalmic drugs and technology.
FDA issues warning letter to maker of homeopathic eye drops
The FDA issued a warning letter to Deserving Health International, a Canadian homeopathic drug maker, for failing to implement an appropriate manufacturing process to ensure the sterility of their Symbio Muc Eye Drops 5X.
Net neutrality repeal may diminish telemedicine access, harm small practices
The repeal of net neutrality as voted on by the Federal Communications Commission could lead to unintended and devastating consequences for physicians in small practices, as well as telemedicine and patients in rural areas that receive state-of-the-art medical care through telecommunications, according to experts.
November approvals lead FDA activity in ophthalmology
The FDA’s ophthalmology-related news in November included device, drug and feasibility study approvals.
Vision Council discusses legislative, regulatory issues with elected officials
The Vision Council held its annual Government and Regulatory Affairs Committee Capitol Hill Fly-In this week to better connect member companies and their elected officials.
AOA, Sen. Daines seek tax relief for optometrists
The American Optometric Association is working to ensure that optometry is heard as final changes to the Tax Cuts and Jobs Act are being considered.
Massachusetts ODs continue to seek glaucoma privileges
The Massachusetts Society of Optometrists is working with practitioners, residents and state legislators to ensure its optometric scope of practice is in line with the rest of the country, according to Matthew Forgues, OD, president of the Massachusetts Society of Optometrists, in an interview with Primary Care Optometry News.
Orion cortical visual prosthesis system gets FDA expedited access pathway designation
The FDA has granted expedited access pathway designation to Second Sight Medical Products for its Orion cortical visual prosthesis system, according to a company press release.
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Headline News
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