The European Commission (EC) is proposing a novel cancer screening program that would improve cancer outcomes by fostering more frequent cancer screenings among European Union (EU) member nations. The primary focus is on screening for breast, cervical and colorectal cancers, but the plan carries a lofty target of providing screening services for 90% of those who qualify for screening.
The U.S. FDA posted notice recently regarding a vulnerability seen in the Minimed 600 series of insulin pumps made by Dublin-based Medtronic plc, which exposes the user to the risk of unauthorized access to the pump’s software. The vulnerability could be exploited to interfere with the system’s ability to deliver only the desired amount of insulin, although the FDA acknowledged that no adverse events or complaints have been reported.
A subcommittee of the Senate Judiciary Committee met recently to review the current state of antitrust enforcement in the U.S., and heard from both the Department of Justice (DOJ) and the Federal Trade Commission (FTC) about their enforcement activities. FTC chairwoman Lina Khan acknowledged that the agency had coordinated with the European Commission about the transaction between Illumina Inc., and Grail Inc., activities which she claimed were nothing more than an attempt to promote regulatory efficiency.
President Joseph Biden’s recent statement that the COVID-19 pandemic is over may or may not reflect popular fatigue with the associated public health emergency (PHE), but the statement struck a different tone in some quarters on Capitol Hill. Sen. Richard Burr (R-N.C.) was one of several who argued that the need for the PHE had thus necessarily run its course, with Burr specifically calling into question the need for additional funding for COVID-related federal health efforts.
The U.S. response to the emergence of the COVID-19 pandemic may by now be the stuff of public health policy lore, with both the FDA and the CDC contributing to the chaos in the first months of the pandemic. The Office of Inspector General has issued an analysis of the situation, and while OIG revisited some of the known miscues, the report also made the case that a national strategy for pandemic response will be needed if federal government efforts in the future are to be less a hazard to the lives of American citizens than those seen in the first half of 2020.
Abiomed Inc., has worked the ventricular assist device (VAD) space for a number of years with its Impella series of VADs, and a study coming out of Japan seems to affirm investors’ confidence in these devices. This registry study demonstrated that the combination of Impella devices and extracorporeal membrane oxygenation (ECMO) provides a 30-day survival rate of more than three in four patients with cardiogenic shock, an outcome that is said to support the notion that the native heart tissue can recover from myocarditis, an especially salient consideration for those who contracted the SARS-CoV-2 virus.
The U.S. NIH is not generally regarded as a wellspring of concepts and policies in the world of artificial intelligence (AI), but that perception may change soon thanks to the agency’s Bridge2AI program. The agency announced recently that it will drop $130 million into this program over four years in an effort to develop standards for data used in AI research, a key development for device makers seeking to sell products that use these complex algorithms.
The U.S. NIH is not generally regarded as a wellspring of concepts and policies in the world of artificial intelligence (AI), but that perception may change soon thanks to the agency’s Bridge2AI program. The agency announced recently that it will drop $130 million into this program over four years in an effort to develop standards for data used in AI research, a key development for device makers seeking to sell products that use these complex algorithms.
The Biden administration’s views of mergers and acquisitions have veered sharply from those of the previous administration, but Jonathan Kanter, assistant U.S. attorney general, said recently that there is more to come. Kanter said the Department of Justice (DOJ) and the Federal Trade Commission (FTC) will shortly publish draft guidelines that would place the burden on the parties to these M&A transactions to prove the transaction is not anticompetitive, upending the historical presumption that the plaintiff is liable for demonstrating the anticompetitive nature of the proposed transaction.
Medical device manufacturers have railed against payers’ prior authorization practices for years, but the U.S. Congress seems poised to finally address the issue, at least in the context of Medicare Advantage (MA) plans. The House of Representatives has passed the Improving Seniors’ Timely Access to Care Act of 2021, a development that drew the applause of both the Medical Device Manufacturers Association (MDMA) and the American Society of Radiation Oncology (ASTRO), a clear display of the broad support enjoyed by the legislation.
