The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.
The recent controversy over the use of paclitaxel in the peripheral vasculature has clouded the larger debate over whether bypass is superior to endovascular therapies for the lower limbs. However, a new study suggests that nitinol stents provide a feasible alternative to bypass even for lesions of the femoropopliteal artery that are 30 cm in length.
The U.S. FDA has engaged in an overhaul of its software policies in the wake of the mandates spelled out by the 21st Century Cures Act. However, those policies are still a work in progress, as a recent FDA webinar made clear. The FDA won’t have long to put those policies into place as the U.S. House of Representatives is considering a follow-on to the Cures Act, dubbed Cures 2.0, which will impose yet more changes on the agency’s approach to software regulation.
The FDA has posted the names of the companies that will take part in the ethylene oxide (EtO) challenge in response to the recent state action against EtO device sterilization sites, but the agency also has opened a pilot program for a streamlined notification process for changes to sterilization that should be faster and leaner than the usual PMA supplement.
The case of Arthrex v. Smith & Nephew, Inc., has raised a host of questions about the appointment of judges to the Patent Trial and Appeal Board (PTAB), and witnesses at a congressional hearing said a Supreme Court review might be two years in coming. Any such resolution might not clear out the thicket of underlying legal questions, however, and thus the witnesses urged Congress to take action quickly even as the Federal Circuit considers an en banc hearing of the matter.
The FDA’s safety and performance-based pathway for 510(k) devices promises to streamline premarket filings, and the FDA’s Jason Ryans said on a recent webinar that any changes to the related product-specific guidances would be applicable only prospectively. Ryan made no mention of a grace period for impending applications, however, suggesting that any such devices may have to be reworked or resubmitted into a more conventional premarket channel if they do not meet the new requirements.
Stephen Hahn, of the MD Anderson Cancer Center, generally managed to avoid any controversy in today’s 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.
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.