Nanox Demystified | NPs Intrusion | Radiomics’ Crisis

“This is happening because we physicians have gotten fat and lazy, and sold ourselves to MBAs.”

An auntminnie.com forum post about nurse practitioners’ continued expansion into physicians’ turf.

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  • GE Healthcare – Providing point of care ultrasound systems, from pocket-sized to portable consoles, designed to support your clinical needs and grow along with your practice.
  • Healthcare Administrative Partners – Empowering radiology groups through expert revenue cycle management, clinical analytics, practice support, and specialized coding.
  • Hitachi Healthcare Americas – Delivering best in class medical imaging technologies and value-based reporting.
  • Nuance – AI and cloud-powered technology solutions to help radiologists stay focused, move quickly, and work smarter.
  • Riverain Technologies – Offering artificial intelligence tools dedicated to the early, efficient detection of lung disease.

The Imaging Wire

Nanox Demystified

There’s been plenty said and written about Nanox since it came on the scene, but aside from impressive funding and plenty of “disruption” forecasts, the company has remained quite mysterious. That just changed with Nanox’s pre-IPO SEC filing, which clarified many of those mysteries.

  • Nanox Tech – Nanox will build its business around its X-ray source technology, which works like legacy X-ray analog cathodes, but has a range of advantages (lower costs, smaller size, lower voltage). The first Nanox.ARC imaging systems will be 3D tomosynthesis devices, positioned as CT replacements / alternatives.
  • Nanox Platform – Nanox’s X-ray tech might be its foundation, but its strategy will rely on services delivered through the Nanox.CLOUD platform. This platform will support what Nanox envisions as an “end-to-end” medical imaging service (image repository, radiologist matching & review, AI diagnostics, billing, etc.) and will allow it to offer the devices through a ‘medical screening as a service’ (MSaaS) structure. This will also require Nanox to form partnerships across the imaging process.
  • FDA Path – Nanox submitted a FDA 510(k) application for a single-source version of the Nanox.ARC system in January 2020 and is currently performing FDA-requested tests that it will submit in Q3 2020. The company also plans to submit a 510(k) application for a multi-source Nanox.ARC system in Q4 2020, which they would take to market if it’s approved.
  • Commercialization – If FDA approvals go as planned, Nanox will deploy its first Nanox.ARC systems in early 2021, targeting a 1k system installed base by the end of 2021 and 15k systems by 2024. That might seem ambitious, but Nanox believes that its low system costs and MSaaS model will give it growth opportunities in developing regions and disruption opportunities in developed regions.
  • Risks – There was no shortage of potential challenges detailed in the “risks” section of Nanox’s SEC filing, but the main challenge is that Nanox’s disruption goals will require it to execute an unproven business model using an unproven technology that hasn’t been approved by the FDA. Still, you can’t disrupt an industry like medical imaging by sticking to what’s already established.

The Wire

  • AUC in 2022: CMS extended its Appropriate Use Criteria (AUC) and Clinical Decision Support (CDS) testing period until the end of 2021, giving everyone another year to prepare. During the extended testing period, CMS expects ‘ordering professionals’ to begin using qualified clinical decision-support mechanisms (CDSMs) and providing ‘furnishing practitioners and providers’ sufficient AUC / CDS information to support their Medicare claims.
  • Gadavist Bulk Package: Bayer announced the FDA approval of its Gadavist Imaging Bulk Package (30 mL and 65 mL sizes) and its MEDRAD Imaging Bulk Package Transfer Spike, which become the first FDA-cleared GBCA system for multi-patient dosing. This very practical solution eliminates the waste associated with individual GBCA vials (one-patient per vial w/ excess discarded), benefitting rad techs (improved workflow, increased patient focus), administrators (reduced costs / waste, increased productivity), and patients (greater dosage consistency).
  • Radiomics’ Reproducibility Crisis: A new paper in European Radiology detailed the challenges keeping radiomics out of clinical practice, despite a steady flow of positive / optimistic radiomics study results (including in The Imaging Wire). The authors warned that radiomics research’s “many pitfalls” (mainly: poor research quality, inconsistent methodology) put it at risk of a “reproducibility crisis” and encouraged researchers to produce higher quality radiomics studies with a focus on clinical impact.
  • NP’s CA Expansion: A California state bill (AB-890) to expand nurse practitioners’ ability to provide care without physician supervision (including ordering, performing, and interpreting images) continues to make its way through the legislative revision process. The latest revisions published last week address board certification, physician consultation rules, and disciplinary action, but keeps most NP role expansions intact. Needless to say, not all physicians are OK with this expansion.
  • Canon & Zebra: Canon Medical Systems USA will integrate Zebra Medical Vision’s AI1 bundle into its products and offer it across the US, representing a big step into the AI space for Canon and into the modality space for Zebra. Indeed, this is a major partner expansion for Zebra, which primarily worked with PACS and software players before now (e.g. Nuance, Change, Intelerad, Philips/Carestream).
  • ACR & MITA Want More: The ACR and MITA approve of the USPSTF’s new low-dose CT lung cancer screening recommendations (dropping starting age from 55yrs to 50yrs, dropping risk threshold from 30-pack-years to 20), but they’d like even it more if the task force made its screening guidelines broader. The groups asked the USPSTF to eliminate smoking cessation quit dates and upper age limits from its recommendation (currently 15yrs and 80yrs-old), suggesting that these decisions should be made by physicians and patients.
  • MRI Rideshare’s Mixed Results: A Mass General Hospital pilot program that provided at-risk patients with rideshare transportation to MRI appointments significantly improved patient timeliness and imaging center efficiency, but wasn’t able to reduce missed appointments. The program offered rideshare transport to patients who discussed cancelling or rescheduling during their appointment reminder call. The JACR-published study reviewed 7,707 MRI patients (151 that used the MRI rideshares), finding that rideshare patients arrived an average of 54.8 minutes before their appointments (vs. 43.4 min for non-rideshare patients), but rideshares didn’t change cancellation rates (29% w/ rideshare, 27.9% without).
  • Philips’ MR-STAT Partnership: Philips and University Medical Center Utrecht launched a research partnership focused on advancing and eventually commercializing MR-STAT quantitative MR technology (originally developed by UMC Utrecht). Called a “paradigm shift in MR,” MR-STAT relies on a new smart acquisition scheme and machine-assisted reconstruction to deliver multiple quantitative MR parameters in a single scan.
  • United Imaging’s PET DLR: United Imaging announced the FDA approval of its uAI HYPER DLR (Deep Learning Reconstruction) solution intended to reduce noise in FDG PET images, allowing shorter scan times without affecting image consistency. uAI HYPER DLR is immediately available for integration with all of United Imaging’s molecular imaging systems in the U.S. as part of its Software Upgrades for Life program.
  • MRI Staff’s High TCO: Staffing costs are the greatest contributor to MRI systems’ total cost of ownership. That’s from an ISMRM 2020 presentation covered by auntminnie.com that found staffing (particularly techs) represents 35% of an MRI’s 10-year TCO, nearly double the actual cost of acquiring the system (17%).
  • Mobile Screening’s Benefits: A new MD Anderson study detailed a mobile mammography screening program that helped identify early stage breast cancer among patient groups who generally face barriers to screening. The study analyzed 9,327 mobile exams performed over a 5-year period, identifying 14 cancer cases (11 invasive, CDR = 1.5 per 1k), while leading to 1,686 recalls (recall rate = 17.8%) and 98 biopsies. Underscoring the program’s barrier-breaking results, 79% of the patients were not screened in any other way during the period and 94% identified as minorities.
  • GE’s Brain MRI Showcase: GE Healthcare’s ISMRM 2020 showcase brought a range of brain MRI launches and debuts, including its flagship SIGNA 7.0T MRI and its research-focused SIGNA ultra-high performance (UHP) 3.0T MRI and head-only MAGNUS gradients MRI. GE highlighted the SIGNA 7.0T’s 60cm bore (ideal for brain and extremity imaging), UltraG gradient technology (its most-powerful whole-body gradient coil), and its use of the company’s familiar SIGNAWorks applications platform.
  • Comparable ABB-MRI: Abbreviated breast MRI’s (ABB-MRI) momentum continued this week, as a ISMRM presentation covered by auntminnie.com found that ABB-MRI’s diagnostic performance is comparable to full protocol MRI. The meta-analysis review of 13 studies found that ABB-MRI had similar sensitivity, specificity, and AUC for screenings (90% vs. 92%, 92% vs. 95%, 0.94 vs. 0.97) and enriched patients scans (93% vs. 93%, 83% vs. 84%, 0.94 vs. 0.94). This study follows other recent research supporting ABB-MRI’s performance among higher risk women, women with dense breasts, and its performance versus DBT.
  • Canon SOLTUS 500: Canon Medical announced the U.S. launch of its new SOLTUS 500 mobile X-ray system, touting its combination of workflow and productivity improvements. The FDA-cleared system is highlighted by its ease-of-use (tubehead controls, 8.4” panel, dual collimator control), expanded detector wireless range, a new exam workflow package, and new safety and sanitary features.

The Resource Wire

– This is sponsored content.

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