Regulatory/Legislative News

Days before an expected vote, HHS Secretary Tom Price, MD, said he has not seen the U.S. Senate bill to overhaul the nation’s health care system.

The National Institute for Health and Care Excellence in the United Kingdom has issued a final appraisal determination recommending Ozurdex for the treatment of noninfectious posterior uveitis, according to an Allergan press release.

The FDA has granted 510(k) clearance for the Zepto capsulotomy system from Mynosys Cellular Devices for lens capsulotomy during cataract surgery, according to a press release.

The Congressional Budget Office — a non-partisan scoring agency — and the staff of the Joint Committee on Taxation released its cost estimate for the House-passed version of the American Health Care Act and estimated $119 billion in net savings from 2017 to 2026 for the proposed health care plan.

The Trump administration’s proposed 2018 budget would decimate scientific research and innovation while jeopardizing millions of Americans’ access to essential health care and preventive services, according to leaders of national medical organizations.

The EVO+ Visian ICL with aspheric optic has received a CE mark for commercialization in the European Union, according to a STAAR Surgical press release.

The FDA has accepted a new drug application for Rhopressa and set a PDUFA goal date of Feb. 28, 2018, according to a press release from Aerie Pharmaceuticals.

LOS ANGELES — The FDA has granted 510(k) clearances for integration of the Oculus Pentacam HR and Pentacam AXL, and the Topcon Aladdin topographer with the Lensar Laser System with Streamline III, according to a Lensar press release.

The U.S. House of Representatives today narrowly approved legislation to overhaul the nation’s health care system, voting by a slim margin to replace the Affordable Care Act, or ACA, with a refurbished version of a Republican-penned bill that was pulled just weeks ago because of a lack of support.

Vitesse, a hypersonic vitrectomy system, has received 510(k) clearance from the FDA, according to a press release from Bausch + Lomb.