The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.
The FDA’s device center has repeatedly asserted that its goal is to ensure that patients in the U.S. will always have first access to the latest and greatest in med tech, and a new priority document resurrects that goal in principle. However, the latest strategic plan qualifies that metric as half of manufacturers of novel technologies bringing their devices to the U.S. market “first, or in parallel with other major markets” by the end of 2025.
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
The U.S. Department of Justice (DOJ) reported Feb. 1 that it had recouped more than $5.6 billion in settlements in connection with False Claims Act litigation (FCA) in 2021, with $5 billion of that amount derived from action against the health care industry.
The COVID-19 pandemic shone a bright light on the need for and utility of telehealth, which in turn prompted the U.S. Centers for Medicare & Medicaid Services (CMS) to temporarily expand telehealth coverage. Some of those coverage policies are set to expire when the public health emergency ends, and a group of stakeholders, including the American College of Cardiology, are urging Congress to pass legislation that would make some of these benefits permanent, a potential boon for many telehealth entities.
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
The availability of rapid antigen tests for the COVID-19 pandemic has been far short of ideal in recent weeks despite a recent order by the Biden administration for half a billion tests. The question of whether additional federal dollars are forthcoming for additional tests is up in the air, however, due to congressional concerns that there is roughly $800 million in unspent federal dollars, a signal that any additional monies might not be made available any time in the near term.
More than a year into U.S. President Joe Biden’s four-year term, the FDA commissioner seat remains open. While Robert Califf secured a critical endorsement Jan. 31 in his quest for a second term in the post, his hope for a sequel may still be up in the air.
With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
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