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    Once an isolated subspecialty of radiology, imaging informatics has transformed in the last few years into an enterprise asset that encompasses pathology, cardiology, dermatology, ophthalmology, critical care, and more. This evolution calls for new forms of coordination and new strategies to succeed.
    Aetna has become the first national payor to reimburse providers who perform MR-guided focused ultrasound to treat essential tremor that is resistant to medication. Essential tremor is a movement disorder that causes uncontrollable shaking and is estimated to affect 10 million Americans. While available, medications are unable to help many. Focused ultrasound performed in a single, outpatient procedure, however, can, with many patients showing immediate improvement in the tremor of their hand. The procedure is associated with minimal complications, according to Dr. Jeffrey Elias.
    Medical device reprocessing instructions for use (IFUs) has historically been a point of confusion for the healthcare industry due to variability in how they are written. The root of this problem was a lack of standardization. The FDA did provide information on what should be included in an IFU, such as cleaning and sterilizing instructions, but there was no rigor around how to format it. As a result, similar medical devices from different companies often came with very different IFUs.
    Justification for an imaging exam, and the radiation exposure that comes with it, is a fundamental principle behind every patient scan. And yet, by some estimates, anywhere between 20% to 50% of radiology exams are likely to be inappropriate and provide little to no clinical benefit. Researchers from the European Society of Radiology discussed the challenges of justification in a paper.
    Amazon will soon offer its healthcare services to other private employers through the launch of its Amazon Care telemedicine program. The company currently offers the app to its employees in Washington State to allow them to connect with doctors, nurses, and nurse practitioners virtually over the phone, 24 hours a day. It plans, for the first time, to expand the program to employers in Washington interested in the service for their employees and by the summer to all Amazon workers and private employers across the country, reports the Associated Press.
    Canon Medical Systems USA will distribute its Aquilion Large Bore CT and Celestion PET/CT solutions through RaySearch Laboratories’ U.S. sales force. The agreement builds on a partnership between the two, focused on offering U.S. providers an integrated radiation oncology portfolio that creates more efficient workflows for finding optimal cancer treatment plans.
    Siemens Healthineers has announced FDA clearance of its Biograph Vision Quadra PET/CT scanner, which has an extended axial field of view (FoV) that allows for simultaneous whole-body imaging from top of head to thigh. The scanner, which is designed for both clinical and research use, features a 106-centimeter axial FoV that is four times the PET axial FoV of the company’s Biograph Vision 600," said John Khoury, the U.S. vice president of Molecular Imaging at Siemens Healthineers North America. "The new scanner has the same 3.2-millimeter silicon photomultiplier (SiPM) detector technology and Time of Flight (ToF) performance, and the extended FoV allows clinicians to image all the vital organs simultaneously with higher sensitivity." “This has the axial field of view of four Vision 600s,” Khoury told HCB News. “What this means is that clinicians can now observe organ-to-organ interaction.”
    Increased telehealth may present new opportunities for medicare fraudsters, challenges for investigators. Tens of billions of dollars in Medicare fraud occur every year. The total dollar amount of fraud that takes place is not known but a high degree of fraud has, for decades, been seen as one of the program’s major drawbacks. Medicare fraud is common and it is easy to find recent examples on virtually any level of the healthcare system, from emergency response companies, providers, pharmacies, to fraud perpetrated by major insurance companies.
    The healthcare industry is at a tipping point. Patients personally engage in their care more than ever and seek treatment options that are less invasive and more promising. At the same time, the Biden administration has reinvigorated the push toward value-based care that prioritizes value over fee-for-service. These factors are forcing hospitals and healthcare systems to rethink their care delivery model in order to diversify their portfolios and provide high-quality patient care. What if one particular specialty could help the healthcare system meet these critical goals?
    AI potentially introduces new risk that is not currently addressed within the current portfolio of standards and guidance for software As further advancements are made with AI technology, regulators may consider multiple approaches for addressing the safety and effectiveness of AI in healthcare, including how international standards and other best practices are currently used to support the regulation of medical software, along with differences and gaps that will need to be addressed for AI solutions. A key aspect will be the need to generate real world clinical evidence for AI throughout its life cycle, and the potential for additional clinical evidence to support adaptive systems.