In a ruling delivered June 28, the U.S. Supreme Court brought an end to four decades of a practice of judicial deference to federal government agencies in litigation under the Chevron doctrine, a practice that some argue has enabled regulatory mischief.

A trio of regulators devised a series of good machine learning practices in 2021, a key point of consideration for many algorithms that will eventually be used in thousands of medical applications in the coming years.

The device industry has been clamoring for legislation that would require Medicare coverage for FDA-designated breakthrough devices, a wish that is one step closer to fulfillment as of June 27.

The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages.

The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products.

Sometimes a court cites long-standing precedent in deciding how to handle a case, but the U.S. Court of Appeals for the Federal Circuit leveraged a decision it rendered only last year in deciding a patent case between Apple Inc., and Omni Medsci Inc.

Medicare spending in the U.S. continues to climb at a worrying pace, given that policymakers are apt to respond by putting the squeeze on the doctors and hospitals that purchase and implant medical devices.

The trade secret dispute between Acton, Mass.-based Insulet Corp. and Eoflow Co. Ltd., of Seongnam, South Korea, addresses several key questions in the area of intellectual property law, including the circumstances in which injunctive relief is and is not appropriate.

The recent conviction of Ontrak Inc. CEO Terren Peizer for insider trading was conspicuous on two counts, including that it was the first time such a conviction had been obtained solely for trading conducted under a government-approved insider trading policy. More worrisome for industry, generally, is the case is another example of federal prosecutors’ ever-growing use of data and analytics to root out violations of SEC law. This is a trend that seems destined to grow with advances in artificial intelligence.

The annual U.S. Medicare inpatient rule typically encodes a number of proposed reassignments of procedures between diagnostic-related groups , and the draft rule for fiscal year 2025 proposes several such changes in the area of orthopedic surgeries. The Medical Device Manufacturers Association lauded the proposed changes, arguing that the existing DRG code structure has failed to keep pace with the growing number of procedures for the lumbar spine, not to mention the significant cost differential associated with each.