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Very Different AI Pathways | Another Extender Debate

“This isn’t about patient safety, this is just protectionism.”

One radiographer’s response to the Royal Australian and New Zealand College of Radiologists’ position against radiographers “seeking to practice beyond their scope of training.”


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The Imaging Wire


Two Very Different AI Pathways

Lancet Digital Health just published an interesting comparison of FDA / CE approved healthcare AI devices, providing insights into how these two very different regulatory pathways shape each regions’ AI arenas. Here are some details:

  • Approved AI/ML – The study identified 222 FDA-approved AI/ML-based medical devices and 240 devices with European CE marking, including 124 devices that are approved by both agencies.
  • Two Regulatory Paths – The European AI regulatory process has proven to be much more efficient, or “potentially relatively less rigorous.” Eighty of the AI/ML-based devices that are approved in both regions were first approved in Europe (vs. 44 first approved in the U.S.), with European approvals coming a median of 137 days before FDA 510(k) approvals.
  • Approved AI Growth – As you might expect, the study found a consistent increase in annual healthcare AI approvals from 2015 (13 CE, 9 FDA), 2016 (27 CE, 13 FDA), 2017 (26 CE, 32 FDA), 2018 (55 CE, 67 FDA), and 2019 (100 CE, 77 FDA). The first quarter of 2020 brought 19 CE approvals and 24 FDA clearances, although it’s likely COVID affected approvals since then.
  • Radiology Focus – The vast majority of the FDA/CE approved AI devices were intended for radiology (126 CE, 129 FDA), followed by cardiology (24 CE, 40 FDA), and neurology (19 CE, 21 FDA). And most of the cardiology and neurology devices were likely imaging focused.
  • The Takeaway – All this AI approval data is pretty interesting on its own, but it’s mainly intended to support the study’s argument that FDA and CE regulators need to evolve their AI regulatory processes with a focus on pathway standardization, process transparency, and creating a public database of all approved AL/ML devices.



The Wire

  • Another Radiology Extender Debate: The radiology extender debate reemerged this week after RANZCR’s dean voiced concern over radiographers “seeking to practice beyond their scope of training” (assessing referrals, interpreting images, communicating findings) and vowed that the Aussie radiologist society will fight these trespasses. The global radiographer community was quick to push back against what they viewed as RANZCR’s “protectionist” efforts, listing examples of how greater rad tech involvement has benefitted the specialty, the fact that RANZCR showed no data to support its position, and warning of the patient safety risks that this policy poses.
  • Probo Expands: Probo Medical hit another expansion milestone with its acquisition of British multi-modality equipment sales, service, and parts company, Mount International United Services (services >250 NHS trusts). This is a big step for Probo, which first expanded beyond ultrasound and outside of the U.S. through a pair of February 2020 acquisitions.
  • UVA’s Impressive Integration: When the University of Virginia Novant Health System integrated its online image viewing portal directly into its EHR patient portal in 2019, the number of unique UVA patients who accessed their images online grew by 586% (1,925 in the 5-months before integration to 13,202 in 5-months after). That’s pretty remarkable, and it’s detailed in a new JACR paper covering the integration of UVA’s MyView and Epic MyChart portals and the effectiveness of its organic rollout.
  • IR & Surgical X-Ray’s Rebound: After the COVID pandemic dragged down global interventional X-ray and surgical X-ray equipment revenues in 2020 (-17.4% & -16.3%), Signify Research forecasts that these segments will gradually rebound from 2021 to 2024 when they reach $3.9 billion (surpassing 2019 levels by 2022).
  • Early MRI for Recurrent Glioblastoma: A German and Austrian research team discovered a new MRI technique that could help identify recurrent glioblastoma six months earlier than current methods. Using brain MRIs from 56 patients who would eventually have recurrent glioblastoma, the team identified a pattern of changes in vascular architecture (decreased vessel density, reduced blood supply, lower oxygen) 190-days before a conventional MRI could diagnose glioblastoma in those same regions.
  • Philips’ AAA 3D US Model: Philips launched its new Abdominal Aortic Aneurysm Model (AAA – FDA & CE cleared), which integrates with Philips’ 3D ultrasound systems to support AAA evaluations. Philips’ AAA Model software automatically segments and quantifies the size of the aneurysm sac for surveillance of known native (untreated) and post-EVAR (treated) AAAs, while giving physicians an alternative to using 2D ultrasound (prone to variability) or CTA (radiation and contrast exposure).
  • ER Screening Opportunity: A new MGH-led study revealed that many U.S. emergency department patients are not up-to-date on their mammography (17.2%), colorectal cancer (16.9%), or lung cancer (25%) screenings, suggesting that ED-based interventions could improve screening adherence. This study comes just a few weeks after results from a separate MGH pilot program suggested that ICU-based interventions could similarly improve screening adherence.
  • HAP’s Typical Practice Impact: Healthcare Administrative Partners just shared a helpful breakdown of how the 2021 reimbursement changes will impact the typical radiology practice. While 2021’s final conversion factor fell by 3.3% to $34.89 (greatest with CT, Mammo, DEXA), these changes will likely amount to a 4.24% drop in professional component reimbursements and 1.78% lower global reimbursements when you weigh each procedure by its typical volumes. The impact on each practice will depend on their modality mix/volumes and structure, noting that many hospital-based practices will see greater declines (high reliance on work RVUs, high CT volumes) compared to imaging center-based practices (global reimbursements).
  • icovid Expands: The Belgian icovid initiative, which uses the icometrix-based icolung AI solution to automate COVID-19 CT assessments, is expanding across Europe and into new areas of COVID AI. The icovid initiative launched in March 2020 through a partnership between icometrix and Belgian medical / research institutions, leading to icolung’s development and rollout. Now, with funding from the European Union’s Horizon 2020 program and commitments from key European research centers (King’s College, Oxford, Heidelberg, others), icovid will expand across 800 European hospitals (at no charge) and begin new research efforts, including detecting Chronic COVID Syndrome.
  • Quantifying RadRes Fatigue: A new study out of Switzerland found that radiology resident-drafted reports require more edits from attending radiologists once fatigue sets in later in the day and later in the workweek. Using data from 117k radiology reports, the researchers found that initial radres drafts and final drafts were less similar at the end of the day during weekday shifts (r = −0.93), weekend shifts (r = −0.72), and especially Fridays (r = −0.95; that’s a 16% same-day decline) compared to their reports drafted earlier in the day.
  • Arterys & Human Bytes Nordic Alliance: Arterys and Danish healthcare AI startup, Human Bytes, announced that Human Bytes will sell and market Arterys’ AI solutions in Europe’s Nordic countries. Human Bytes might be a new name for many readers (it just launched this month), but the company was founded by local medtech veterans with the goal of helping international AI companies navigate the Nordic countries’ unique requirements (it signed a similar deal with Mirada a few weeks ago).
  • CT’s Exposure Risks: Although the likelihood of receiving high radiation exposure (≥100 mSv) from a CT exam is generally low, it isn’t “negligible.” That’s the conclusion of a new study out of the Netherlands (n = 100,672 CT exams, 49,978 patients, 482 who received a high dose) that found the probability of receiving a high effective dose from a single exam is just 0.002%, but it gets higher over 4.5-years (1.9%), and is significant among patients who underwent more than 6 CT exams (16%).
  • HeartFlow’s NHS Boost: HeartFlow just got a UK adoption boost after the NHS issued a 1-3year MedTech Funding Mandate requiring English hospitals to adopt the HeartFlow FFRct Analysis solution, citing its ability to improve care and costs. This adoption will be helped by NHSE’s Innovation and Technology Payment Programme (ITP), which extended its support for HeartFlow FFRct for a third year.
  • Philips’ France & Spain Wins: Philips announced 5-year partnerships with France’s Rennes University Hospital (1,800 beds, top-10 in France) and Spain’s Vithas Group (Spain’s 2nd largest private system). The Rennes University Hospital partnership will cover Philips’ technology (imaging, informatics, AI, interventional) and a range of research and innovation collaborations. The Vithas partnership will expand Philips’ technology (imaging, informatics, and interventional) across Vithas’ locations, including ongoing updates and early access to future technologies.


The Resource Wire

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-- The Imaging Wire team