Intravascular ultrasound is the preferred imaging modality for a number of procedures conducted on the circulatory system, including some procedures performed in the peripheral vasculature, but adoption is seen in some quarters as sub-optimal. A trio of medical journals have published a consensus statement pressing the case for more widespread utilization of IVUS for peripheral artery disease, but one of the sources of drag is poor Medicare reimbursement, a problem that might only be resolved in a piecemeal fashion.
Privacy laws and enforcement in the U.S. are seemingly growing by the week on both the state and federal levels, with the Federal Trade Commission (FTC) serving as one of the players in the federal enforcement game. The FTC has released a statement warning developers of data that are working as model-as-a-service companies to be wary of any illicit uses of data acquired to assist in development of artificial intelligence algorithms, a warning that these developers and their customers would do well to heed.
Industry may still be less than fond of the failure of the term “recall” to distinguish between corrections and market withdrawals, but the class I recall of the Insulet Omnipod 5 app for Android smartphones is a correction of some importance. This recall, one of the first to be announced by the FDA in 2024, addresses a software problem that could lead to overdose of insulin, a potentially lethal problem for which the company has already provided a fix.
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment.
The U.K. Medicines and Healthcare Products Regulatory Agency finalized its plans for an overhaul of its med-tech regulatory system in a comprehensive approach that captures both in vitro diagnostics and artificial intelligence.
The U.S. Patent and Trademark Office’s inter partes review mechanism has drawn uneven reviews in the past decade or so and Dexcom Inc. has serious misgivings about an attempt by Abbott Diabetes Care Inc. to use the process to invalidate Dexcom patents for continuous glucose monitors.
Switzerland’s regulatory authority for devices and drugs, Swissmedic, decided to revamp how it organizes its postmarket surveillance work, and is also seeking to stand up its medical product surveillance database.
The U.S. FDA might still be seen as the premier med tech regulatory entity in the world, but the agency is badly outnumbered by companies in the life sciences, which are pumping out artificial intelligence algorithms at a breathtaking pace. Further, the FDA must also avoid being lapped by industry in connection with the regulatory novelty known as the predetermined change control plan, a challenge that put the agency’s device center in scramble mode for essentially the entirety of calendar year 2023.
The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.
Intravascular lithotripsy generally scores well for removal of calcification, but the U.K. National Institute for Health and Care Excellence (NICE) is offering only limited endorsement of this procedure for peripheral artery disease (PAD). NICE said one of the problems with the evidence is that this procedure is often conducted in conjunction with other procedures, and thus the agency will have to see more definitive evidence before an unequivocal endorsement is justified.
