Implantation of a foldable high-powered IOL significantly improved uncorrected distance visual acuity and spherical equivalence in nanophthalmic eyes, according to a study.The retrospective case series consisted of 21 eyes of 13 patients with nanophtha…
(MedPage Today) — Small Brazilian study suggests high rate of ocular abnormalities
The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported a measure today that would reduce regulatory hurdles for the approval of medical devices. The “FDA Device Accountability Act of 2015” (S. 1622), sponsored by Sens. Richard Burr, R-N.C.; and Al Franken, D-Minn., and co-sponsored by Mark Kirk, R-Ill., is intended to ensure the “least burdensome means” of evaluating medical devices, according to the bill’s authors. It requires that any FDA employee involved in the premarket submission process of medical devices receives training to make the approval of those devices easier, as well as an audit to assess the effectiveness of their training.
Spectranetics, a Colorado Springs, CO firm, won FDA 510(k) clearance for its Bridge Occlusion Balloon, a device used to block large vessels, typically the superior vena cava (SVC), if a tear happens while removing cardiac leads. Though tears are rare, when they do happen the rapid blood loss can be difficult to manage. The Bridge Occlusion […]
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ATLANTA–(BUSINESS WIRE)–Two products from Axion BioSystems received New Product Awards from SLAS. Lumos and Maestro APEX, enhancements to the Maestro MEA product line, were co-winners of this award.
The U.S. Senate health committee today recommended legislation to strengthen and increase the visibility of medical rehabilitation research at the NIH.The “Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act” (S. 800), sponsored by Sens. Mark Kirk, R-Ill.; Michael Bennet, D-Colo.; Orrin Hatch, R-Utah; Lisa Murkowski, R-Alaska; Johnny Isakson, R-Ga.; and Susan Collins, R-Maine, calls for the development of a comprehensive research plan at the agency to support the recovery of stroke victims and help patients return to work.