“. . .where’s the ROI? Show me that that’s really going to help.”
Joe Marion of Healthcare Integration Strategies, suggesting in a recent Healthcare Informatics interview that the buzz around AI has been “more hype than reality.”
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- Carestream – Focused on delivering innovation that is life changing – for patients, customers, employees, communities and other stakeholders.
- Focused Ultrasound Foundation – Accelerating the development and adoption of focused ultrasound.
- Medmo – Helping underinsured Americans save on medical scans by connecting them to imaging providers with unfilled schedule time.
- Pocus Systems – A new Point of Care Ultrasound startup, combining a team of POCUS veterans with next-generation technology to disrupt the industry.
The Imaging Wire
Here’s one example of potential AI ROI: categorizing and prioritizing scans. A team of UK researchers trained an AI system to perform real-time triage on chest x-rays, resulting in “clinically acceptable performance” and pretty significant time savings. The researchers trained the CNN-based system on 470,388 adult chest x-rays, using a homegrown Natural Language Processing (NLP) system to extract labels that are used by the algorithm to prioritize each image as “critical, urgent, non-urgent, or normal.” When tested with a set of 15,887 radiographs, the AI system was able to distinguish normal and abnormal images with relatively high accuracy (sensitivity 71%, specificity 95%, PPV 73%, NPV 99%), while reducing reporting delays for critical findings from 11.2 to 2.7 days, and reducing urgent imaging findings from 7.6 to 4.1 days.
United Imaging’s Game Changer
United Imaging Healthcare announced the FDA clearance and early-2019 launch of its uEXPLORER total-body PET/CT system, which boasts the title of “the world’s first medical imaging scanner that can capture a 3D picture of the whole human body at once.” Co-developed by a UC Davis-led team, the uEXPLORER captures radiation far more efficiently than other scanners, allowing it to produce an image in as little as one second (40x faster than current PET scans) and scan an entire body in as little as 20 to 30 seconds, with a far lower dose (40x lower radiation). There was a rare level of hyperbole in this announcement, as United Imaging heralded it as “truly a game-changing, revolutionary day for the advancement of medical technology,” suggesting that the uEXPLORER will allow United Imaging and its customers to “jointly re-think the role of PET in the North American healthcare system.” Those are big goals, but the uEXPLORER is also a big breakthrough, and its particularly impressive given that it’s only been two months since United Imaging announced that it was “officially open for business in the United States.”
Another New Entry-Level ARIETTA
Hitachi Japan announced the domestic launch of the ARIETTA 50 ultrasound, which appears to represent a completely new entry-level option within its ARIETTA lineup, positioned below the recently-launched ARIETTA 65. The new system is offered in a standard ARIETTA 50 configuration (standard monitor arm, 3 transducer connectors) and a better-equipped ARIETTA 50LE version (flexible monitor arm, 4 transducer connectors), mirroring a configuration strategy that Hitachi uses in other parts of its ultrasound lineup. The Japan announcement placed a specific focus on the new ARIETTA 50’s ease-of-operations (21.5 monitor, 10.1 touch panel, intuitive workflow and UI), compact form factor, and image quality, although its low pricing (the ARIETTA 50’s ¥25m list price is almost half the ARIETTA 65’s ¥48m list price) will play a major role in how and where it sells.
Faced with the challenge of confirming the age of the tens of thousands of unaccompanied minor refugees coming into Germany (18yrs and under get to stay), the German government is launching a €1 million study to see if they can use ultrasound scans for age verification. Germany’s ultrasound age verification study comes after the German Medical Association rejected a previous proposal to use X-ray for age verification due to ethical and medical objections (radiation, inconsistencies in bone growth). This is wild, but far from unprecedented. Imaging-based age verification exists in other European countries, with Belgium and Italy using X-ray and Sweden using MRI (all voluntary age tests), while imaging is also used by FIFA to prevent “age doping” in its youth soccer leagues.
FDA Closer to Streamlining 501(k) Process
FDA rolled-out finalized plans to expand the use of its Abbreviated 510(k) program, including a de-emphasis on older predicate devices for approvals and new efforts to streamline the approval process. The final guidance was headlined by plans to allow manufacturers to use device performance data to prove equivalence to a predicate device, rather than requiring direct comparison testing of the two devices. FDA also requested feedback on ways to encourage the use of newer predicates, suggesting that it may ease-up on its November 2018 proposal to limit reliance of predicate devices older than 10 years, particularly for “well-established technologies” without a need for improvements.
- Siemens Healthineers announced the FDA clearance of its new Multix Impact floor-mounted DR system, combing a number of workflow enhancing features (floating flat table, in-room touch UI, wireless detectors, control room positioning camera) with a “highly competitive price.” The Multix Impact will replace the nearly 5-year-old Multix Select DR, supporting sites with limited space or where a ceiling mounted X-ray tube isn’t feasible, and specifically targeting smaller locations within the larger healthcare system.
- The Emory University Hospital neuroradiology department highlighted the positive results of its new Brain Tumor Reporting and Data System (BT-RADS), a structured brain MRI reporting system developed based on feedback from staff responsible for direct care of brain tumor patients (n=55). Nine months after BT-RADS’ implementation, a follow-up survey (n=38, scored 1-5) revealed greater overall satisfaction with the new reporting system (4.3 vs. 3.7), and improved perceptions regarding: report consistency (4.3 vs. 3.4), report ambiguity (4.2 vs. 3.2), radiologist/physician communication (4.5 vs. 3.8), facilitation of patient management (4.2 vs. 3.6), and confidence in reports (4.3 vs. 3.5). BT-RADS also achieved solid adoption progress, as 81% of all brain tumor reports were dictated using the new template by the 9th month.
- EBM Technologies announced the Class II FDA clearance of its Rad@ remote radiology reading system for diagnostic reading, significantly expanding the iPad Pro-based “mobile PACS” system’s utility. Rad@ first gained FDA clearance in January 2017, but was limited to medical imaging viewing before gaining it’s new diagnostic clearance.
- A new study from a team of Johns Hopkins neuroradiologists suggests that non-contrast head CT scans provide little value for ED patients with sudden/severe headaches, unless the patients have specific high-risk “red flags” (intracranial pathology, cancer, immunocompromising disease, or recent head trauma). This argument against the ACR’s current recommendation is backed by the JHU team’s study of 224 patients with sudden/severe headaches that found nearly every patient with a history of migraines (n=132) had a negative scan (one patient had a false-positive), while 6.5% of the high-risk patients’ scans (n=92) revealed critical findings and 3.3% of the high-risk scans required intervention or follow-up.
- iSchemaView and NeuroLogica announced a global partnership that will integrate iSchemaView’s RAPID cerebrovascular imaging platform with NeuroLogica’s portable CereTom CT scanners for use in Mobile Stroke Units and Intensive Care Units. The companies highlighted how the combination of CereTom and RAPID technologies will allow clinicians to quickly identify the right intervention, including on-site treatment with clot-busting agents or thrombectomy. iSchemaView RAPID was just approved for identifying patients who would benefit from thrombectomy last week.
- A new study published in JACR found that breast cancer screening bundled payment models are feasible, arguing that bundled models would also be effective with DBT screening. The researchers compared 59,000 screening exams from two large academic facilities, finding nearly identical Medicare-normalized prices for breast cancer screening bundles before and after the implementation of DBT ($182.86 in 2013 vs. $182.68 in 2015) . The researchers found that a DBT-included bundle would drive a $53 price increase, but suggested that this may be justified by DBT’s lower recall rates and greater effectiveness.
- Research published by Academic Radiology adds some support to this DBT argument (above), finding that DBT screening reduces recall rates and results in fewer patients committing to short-term follow-ups. The study looked at 11,478 digital mammography screening exams and 9,350 DM+DBT screening exams, finding that the DM+DBT group had a lower recall rate (11.8% vs. 13%) and a fewer short-term follow-ups (2.4% vs. 3.4%) than the DM group.
- Fujifilm announced a trio of new DR deals with Huggins Hospital (New Hampshire; 1 FDR Go PLUS portable system, 1 FDR Visionary Suite X-ray room), John Hopkins All Children’s Hospital (St. Petersburg, Florida; 4 FDR GO Plus portable DR systems, 1 FDR D-EVO GL detector), and Los Angeles County Department of Health Services (20 FDR Go PLUS portable systems).
- Carestream Health announced plans to showcase the latest version of its Vue Clinical Collaboration Platform at HIMSS in February. The new version includes a zero-footprint offering with additional modules and includes report analytics using natural language processing (NLP) to enable data-mining of diagnostic reports for quality measures and research.
- A study by a team of German researchers found that protective eye lenses resulted in artifacts in 95.4% of head CT examinations (n=261 consecutive exams), with cerebral artifacts in 27.8% of cases (often due to the detector’s cranial positioning), although only 5.8% of the exams with artifacts had a risk of misinterpretation. The artifacts were due to the eye lens improperly covering the protector in 24.9% of all cases.
The Resource Wire
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- Carestream Health was awarded 42 new patents from the U.S. Patent and Trademark Office and 37 new patents in European and Asian countries last year, including patents for extremity CT systems and image quality enhancing-patents across its portfolio.
- The University of Queensland received $10 million in funding from the Australian Minister for Health to support clinical research on a potential Alzheimer’s disease treatment that uses focused ultrasound and microbubbles to open the blood-brain barrier (BBB).
- The POCUS Systems founding team has over 80 years of combined experience in the ultrasound industry.
- The New York Times just revealed widespread confusion over healthcare prices, representing a major barrier for patients trying to shop around for the best value. These are the exact patients who can be helped by the Medmo platform, which connects high-deductible patients with radiology centers, ensuring the best price for patients and a profitable revenue stream for imaging centers