Rochester, N.Y.-based Carestream Health Inc. has won the FDA’s nod for its Dual-Energy imaging technology and Focus 35C detector with Image Suite software. The company plans a global launch of the Focus 35C by the end of the year, with U.S. rollout of Dual-Energy early next year.
Stephen Hahn of the MD Anderson Cancer Center generally managed to avoid any controversy in the Nov. 20 Senate confirmation hearing for the FDA commissioner’s job, stating for instance that he is “open to all science and data that could potentially support” drug reimportation as a solution to the drug pricing problem.
The U.S. FDA has granted breakthrough device designation for Bioventrix Inc.’s Revivent Tc Transcatheter Ventricular Enhancement System for heart failure following a heart attack. The system is designed to exclude scar tissue that has formed on the left ventricle in a procedure that is less invasive than current medical options and better than drug therapy, allowing healthy heart tissue to function more efficiently. The left ventricle is the heart’s pumping chamber, and scarring can prevent it from contracting and providing the steady circulation of blood that the body needs.
The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.
The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age. Specifically, the FDA indication said that "Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal."
The U.S. FDA draft guidance for appeals for denial of certificates for export indicated that the scope was limited to devices exported from physical locations in the U.S. This provision appears in the final guidance as well – despite arguments that it flies against the text of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)
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