“Good news! As part of the funding bill Congress passed yesterday, the FDA must now ensure mammography reports include appropriate breast-density information.”
A tweet from Senator Dianne Feinstein, sharing the good news that the 1,169-page funding bill included a range of new breast density mammography reporting requirements.
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Breast Density Gets Federal Support
In addition to keeping the government open and granting $1.375 billion for a 55-mile border “pedestrian fence,” last week’s federal funding bill included a new requirement that should help improve breast density awareness across the country. Going forward, mammography reports will be required to provide information on each patient’s breast density, the effect of breast density on mammogram accuracy, and a reminder that patients with dense breasts should discuss their situation with their healthcare provider. This requirement was understandably overshadowed by the bill’s main components and Trump’s subsequent national emergency threats, but it’s still a big deal for breast health, creating federal-level support for breast density awareness for the first time.
EchoNous expanded its portfolio of nurse-targeted ultrasound scanning tools with the launch of the new EchoNous Bladder, joining the still-new EchoNous Vein and compatible EchoNous AI Station. The new bladder scanning tool combines a data-rich fanning motion, a built-in CNN algorithm, and a “rugged” probe design to help nurses determine patients’ bladder volume faster and more confidently. EchoNous specifically emphasized the bladder tool’s performance with pregnant and postpartum patients, its AI-supported volume calculations, and its all-electronic and non-mechanical design, noting that existing bladder scanners require manual calculations and are still using “outdated” mechanical probes.
GMA’s Thermography Warning
Good Morning America’s 4.5 million daily viewers learned what breast imaging professionals have largely agreed on: sufficient breast cancer screening requires more than just thermography, regardless of the thermal imaging techniques’ radiation-free benefits and fringe mammogram-alternative adoption. The TV segment detailed the experiences of two women who developed breast cancer after missed thermography-based diagnoses and provided some insights into thermography’s emergence as an alternative screening method, while serving as an effective and unfortunate reminder of the importance of mammogram-based screening.
Probo Acquires Trisonics
Probo Medical continued to put its PE funding to use, acquiring Pennsylvania-based ultrasound systems and service provider, Trisonics. The acquisition comes less than a year after Probo Medical and MedCorp merged to become one of the largest ultrasound equipment resellers in the US. The addition of Trisonics further boosts Probo’s service capabilities and expands its footprint to the eastern US. Probo is reportedly still “looking to continue to expand through acquisition,” contributing to a growing consolidation trend in the independent ultrasound sales, service, and refurbishing channel.
A team of SUNY Buffalo researchers developed a tool that ‘teaches’ computers to annotate medical images, allowing radiologists and pathologists to perform analysis without machine learning knowledge or computer engineer ML training support. The “automatic, human-in-the-loop segmentation” tool automatically improves annotation and segmentation of medical images based on what it “learns” each time a clinician redraws a boundary on an image to pinpoint a particular structure or abnormality. Although SUNY Buffalo’s article largely focuses on pathology applications, it’s also intended for use by radiologists, and the theory and technology behind this new technique is promising for all medical imaging applications.
- A team of South Korean and German researchers found that a new PET/CT radiotracer, called F-18 GP1, achieved “excellent” image quality when visualizing acute venous thromboembolism (VTE) blood clots in veins and arteries. In their study, F-18 GP1 was able to detect thromboembolic foci in 100% (20/20) of patients with either Deep Vein Thrombosis or Pulmonary Embolism, while detecting 89% of vessels with DVT (68/76) and 60% of vessels with PE (146/245). The new tracer also outperforms conventional methods at distinguishing old thromboemboli from new and identifying potentially unstable thromboemboli.
- Philips Healthcare announced its new Zenition mobile C-arm series, expanding the company’s C-arm portfolio and adopting many of the features introduced in its Azurion image-guided therapy platform (image capture, image processing, tablet-based user interface). The new Zenition 70 Flat Detector systems and Zenition 50 Image Intensifier systems will make their debut at the upcoming ECR show, but have already gained FDA and CE Mark clearance and are slated to launch in the US and continental Europe (Germany, Austria, Switzerland) in H1 2019.
- Mirada Medical announced the FDA 510(k) clearance of its Simplicit90Y dosimetry software, which it developed with BTG Interventional Oncology, and launched in Europe in 2016. Simplicit90Y offers digital processing, image manipulation, and quantification analysis to support the review and reporting of medical images, allowing personalized planning and validation for liver cancer patients who undergo TARE procedures.
- NIH-funded researchers from Columbia University found that neuromelanin-sensitive MRI (NM-MRI) may prove to be an effective way to measure dopamine in people with schizophrenia and an indicator of the severity of psychotic symptoms. The researchers also highlighted NM-MRI’s radiation-free and non-invasive advantages versus current techniques, especially for pediatric patients and for ongoing monitoring, while setting their sights on its ability to predict schizophrenia in the future.
- Canon Medical Systems announced the Japan launch of its DoseXross dose control workstation, allowing radiology department personnel to analyze exposure data and manage their imaging systems to maintain safe and effective dosage levels.
- Radiology-related negligence lawsuits made the news again this month, emphasizing the high stakes of this specialty. A 58-year-old Illinois man was awarded $20.6 million ($13.5 from hospital system, $7.1 by doctors) after a pair of St. James Hospital radiologists missed his bleeding aneurysm in a CT scan and then a vascular surgeon missed the bleeding again the following day, leading to permanent paralysis and a range of other issues. Meanwhile, the family of an Arizona woman who died of gadolinium-related anaphylactic shock during an MRI scan at Canyon Vista Medical Center filed a wrongful death lawsuit against a wide range of defendants, claiming (among other things) that the center’s staff was not trained to identify or treat anaphylaxis and were not aware of an on-site EpiPen.
- Philips Healthcare announced the FDA clearance of its new premium ceiling-mounted DR system, the DigitalDiagnost C90 (already available in EU), which inherits many of the features of the DigitalDiagnost 4.0x (e.g. Eleva UI, Unique 2 image processing) while adding a new live camera to support patient positioning and reduce re-takes.
- The American Society of Breast Surgeons published new guidelines recommending genetic testing, in addition to standard imaging exams, for all breast cancer patients to determine hereditary risks, citing mounting evidence in support of genetic testing and improving costs/availability of the tests. The group specifically recommended that newly-diagnosed patients or those with breast cancer history should receive genetic testing, but also suggested that patients who previously underwent genetic tests or healthy patients that meet certain guidelines should undergo the latest tests.
- With $112 million in Medicare ultrasound reimbursement cuts looming, the ACR is asking America’s radiologists to submit their ultrasound system invoices to help show CMS how much it costs to purchase ultrasound equipment and convince it to reverse the cuts. The ACR and the Ultrasound Access Coalition already convinced CMS to delay the cuts beyond its initial January 2019 target date and now must demonstrate “real world” ultrasound costs before the delayed cuts go into effect, as early as 2020.
- Datatrak International announced the launch of its Electronic Data Capture system (EDC), which combines medical image capture, display, storage, and endpoint adjudication on the company’s Enterprise Cloud platform to support clinical trials processes. The company claims that EDC reduces cost and time inefficiencies associated with adjudicator system integration.
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- Focused ultrasound researchers are making unprecedented progress towards developing life-extending treatments for patients with deadly glioblastoma multiforme (GBM) brain tumors, with key blood-brain barrier (BBB)-related breakthroughs at a range of global companies, academic institutions, and research centers.
- Carestream will showcase its entire portfolio of medical imaging and healthcare IT systems at the European Congress of Radiology (ECR) 2019 later this month.
- The POCUS Systems founding team has over 80 years of combined experience in the ultrasound industry.
- Did you know that imaging patients are most likely to no-show for their procedures on Mondays and Saturdays? By partnering with Medmo, imaging centers can keep their schedules full, despite the inevitable Monday no-shows.