Regulatory/Legislative News

Eyenovia has received Notices of Allowance from the U.S. Patent and Trademark Office for two patent applications providing coverage on physiologic microdroplet ejection diameters and velocities, according to a press release.

EyeGate Pharmaceuticals has addressed three of the four outstanding action items regarding an FDA investigational device exemption amendment filed for its ocular bandage gel, the company announced in a press release.

The FDA recently filed two complaints in federal court seeking permanent injunctions against two stem cell clinics to stop them from marketing stem cell products without FDA approval, according to a press release.

Aerie Pharmaceuticals has submitted a new drug application to the FDA for Roclatan, its once-daily IOP-lowering eye drop, the company announced in a press release.

The FDA has granted fast track designation to AAV-RPGR for the treatment of X-linked retinitis pigmentosa, MeiraGTx announced in a press release.

Some ophthalmologists are interested in an enhanced cataract surgery package with a corresponding added charge and want to know how Medicare would view it.

The United States Patent and Trademark Office has issued a patent to EyeGate Pharmaceuticals for its iontophoretic contact lens, the company announced in a press release.

The FDA has granted 510(k) clearance for the Lensar laser system with Streamline IV to include the creation of corneal pockets and flaps for corneal inlay procedures, according to a press release.

The FDA has permitted the marketing of IDx-DR, the first artificial intelligence medical device to detect more than a mild level of diabetic retinopathy in adults with diabetes, according to a press release.

The Health Insurance Portability and Accountability Act has been something many practices have struggled to remain compliant with since its introduction in 1996. Many practices have introduced HIPAA officers or compliancy administrators who help ensure they stay compliant with HIPPA guidelines of handling of patient protected health information.