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." Read More
The annual American Heart Association's Scientific Sessions saw some significant findings, with the results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial standing out in particular. Of note, investigators found no evidence that invasive procedures – such as stent implants or bypass surgery – in individuals with severe but stable heart disease had lower rates of major, disease-related events vs. those treated with medications and lifestyle changes alone, also known as optimal medical therapy (OMT). Read More
LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022. Read More
Edwards Lifesciences and Medtronic have struggled for supremacy for transcatheter aortic valve devices for several years, but two recent studies suggest the Edwards line of devices provide better outcomes. However, another study gave new life to the notion that TAVR devices are underutilized, signaling that there is plenty of market for both companies. Read More
There are a pair of approved CAR T drugs, Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. and Kymriah (tisagenlecleucel) from Novartis AG, that have been available since 2017 for a few hematological cancers including some lymphomas and leukemias. But little is known about how these engineered chimeric antigen receptor T cells that both target CD19, an antigen prevalent in the cells of many B-cell malignancies, move through the body and proliferate after they are first removed, altered, expanded in number and, finally, returned to a patient's body. Read More
